text:
PART 1 General
Citation and commencement
1
These Regulations may be cited as the Medicines (Products for Human Use) (Fees) Regulations 2010 and shall come into force on 1st April 2010.
Interpretation
2
These Regulations shall be interpreted in accordance with Schedule 7.
PART 2 Capital Fees for Pre-Application Meetings
Interpretation of Part 2
3
In this Part —
“ EU marketing authorization” means —
a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations ;
a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive ; or
a European Union marketing authorization; and
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.
Fee for scientific advice: application for, or variation to, EU marketing authorization
4
Unless regulation 5 applies, the fee payable by a person with whom the licensing authority holds a meeting in order to provide scientific advice with a view to that person making an application for an EU marketing authorization or an application for the variation of an EU marketing authorization, is —
a
£2,378, if the advice provided at that meeting consists of advice in connection with —
i
quality development only; or
ii
safety development only;
b
£2,986, if the advice provided at that meeting consists only of advice in connection with clinical development;
c
£3,309, if the advice provided at that meeting consists only of advice in connection with quality and safety development;
d
£3,917, if the advice provided at that meeting consists of advice in connection with —
i
quality and clinical development; or
ii
safety and clinical development;
e
£4,849, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.
Fee for scientific advice: classification of a medicinal product
5
1
The fee payable by a person with whom the licensing authority holds a meeting to provide scientific advice in connection with the classification of a relevant medicinal product, is —
a
£2,986, if the advice relates to a product which, if reclassified, will be available on general sale; and
b
£3,917, if the advice relates to a product which, if reclassified, will be available without a prescription from a pharmacy.
2
For the purposes of this regulation, a product is on general sale if it is a medicinal product of a description or falling within a class specified in an Order made under section 51 (general sale lists) of the Act .
Fee for advertising advice
6
The fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide advice before the publication of advertising of a medicinal product by that holder’s undertaking on whether that advertising conforms to the requirements of Title VIII of the 2001 Directive, is £2,378.
Fee for pharmacovigilance advice
7
1
The fee payable by a person with whom the licensing authority holds a meeting in order to provide pharmacovigilance advice is —
a
£3,917, in a case where the time taken by the licensing authority to prepare for and attend the meeting is more than six hours;
b
£3,308, in any other case.
2
The time taken by the licensing authority for the purposes of paragraph (1) shall be the aggregate of times spent by each individual engaged in preparing for or attending the meeting on behalf of the licensing authority.
Fee for advice on labelling or leaflets
8
The fee payable by the holder of one or more marketing authorizations with whom the licensing authority holds a meeting in order to provide advice on proposed changes to the labelling or the package leaflets of the medicinal products to which those authorizations relate, is £2,378.
Fee for regulatory advice
9
The fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide regulatory advice to that person, is £2,986.
Fee for advice for other purposes
10
1
Unless paragraph (4) applies, the fee payable by a person specified in paragraph (2) with whom the licensing authority holds a meeting for a purpose specified in paragraph (3) is £4,810.
2
A person who —
a
is, or is to be, a sponsor of a clinical trial;
b
manufactures medicinal products;
c
is, or is to be, responsible for placing medicinal products on the market; or
d
acts on behalf of, or provides advice or assistance to, a person referred to in sub-paragraphs (a) to (c),
is a specified person for the purpose of paragraph (1).
3
A meeting referred to in paragraph (1) is for a specified purpose if it is held to provide advice in relation to —
a
scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product;
b
the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product;
c
the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed in the European Union; or
d
other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorization has been granted for that product or a product of that type.
4
Paragraph (1) does not apply in the case of a meeting where the purpose of such a meeting is to provide only any advice specified in regulations 4 to 9.
5
In this regulation —
“Directive 93/42/ EEC ” means Council Directive 93/42/EEC concerning medical devices ;
“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC ;
“medicinal product” includes a substance incorporated in a medical device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;
“regulatory issues” means issues relating to the application of any EU instrument relating to EU marketing authorizations or to medical devices, or any enactment which implements such an instrument;
“risks” means any risk relating to the quality, safety or efficacy of a medicinal product as regards patients’ health or public health, or any risk of undesirable effects on the environment;
“sponsor” shall be construed in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations ;
and a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of —
a
obtaining an EU marketing authorization, or making a variation to an EU marketing authorization, for that product or a product of that type; or
b
obtaining a design-examination certificate of the type mentioned in paragraph 4.3 of Annex II to Directive 93/42/EEC or a type-examination certificate of the type mentioned in paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.
Time for payment of fees under regulations 4 to 10
11
All sums payable by way of fees under regulations 4 to 10 must be paid within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.
PART 3 Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections
Fees for applications for authorizations, licences or certificates etc.
12
1
Unless regulation 52 (revocations and savings) applies, the application fee for a marketing authorization (other than a European Union marketing authorization), a traditional herbal registration, a manufacturer’s licence, a manufacturing authorisation, a wholesale dealer’s licence or a clinical trial authorisation is —
a
the fee prescribed for that application in Part 2 of Schedule 1; and
b
in respect of an inspection of a site made in connection with that application, the fee payable in accordance with regulations 27 to 32.
2
Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.
Fee for applications for copy certificates of good manufacturing practice
13
The fee payable by an applicant for a certified copy of a certificate of good manufacturing practice issued pursuant to Article 111(5) of the 2001 Directive is £67.
Fees for applications for certificates and copy certificates by exporters of medicinal products
14
1
The fee payable by an applicant for a certificate issued under section 50 (export certificates) of the Act , is —
a
£148, if the applicant requests the certificate to be issued within 24 hours of receipt of the application; and
b
£67 in any other case.
2
The fee in paragraph (1)(a) and (b) is for three identical signed certificates.
3
The fee payable by the applicant for a certified copy of the certificate referred to in paragraph (1) is £33.
PART 4 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
Meaning of “set of applications”
15
For the purposes of this Part, a “set of applications” means —
a
a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in other EEA States, but only if all the applications relate to applications for marketing authorizations in other EEA States that have the same 90 day assessment period for the purposes of Article 28.4 of the 2001 Directive; or
b
a number of applications to competent authorities of other EEA States for marketing authorizations relating to a single United Kingdom marketing authorization, but only if all the applications have the same 90 day assessment period for the purposes of Article 28.4 of the 2001 Directive.
Fees for applications for regulatory assistance under the mutual recognition procedure
16
The fee payable by an applicant to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in another EEA State or in other EEA States, is the fee prescribed in Part 3 of Schedule 1 in connection with the application or set of applications.
Time for payment of fees under regulation 16
17
Unless regulation 41 (applications made by small companies) applies, all sums payable by way of fees under regulation 16 must be paid at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated.
PART 5 Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections
Fees for variations of authorizations, registrations, licences and authorisations
18
1
Unless regulation 52 (revocations and savings) applies, the fee for an application —
a
under regulation 4 (applications for the grant, renewal or variation of a United Kingdom marketing authorization) of the Marketing Authorisation Regulations for the variation of a United Kingdom marketing authorization;
b
under regulation 6 (consideration and grant or refusal, of an application for, or for renewal or variation of, a traditional herbal registration) of the Herbal Regulations for the variation of a traditional herbal registration;
c
under section 30 (variation of licence on application of holder) of the Act for the variation of a product licence, a manufacturer’s licence or a wholesale dealer’s licence; or
d
under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations for the variation of a manufacturing authorisation,
is the fee mentioned in paragraph (2).
2
The fee referred to in paragraph (1) is —
a
the fee prescribed in Part 4 of Schedule 1 in connection with the application; and
b
in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29 and 31.
3
Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.
Fees for amendments to clinical trial authorisations
19
1
A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations relating to amendment of the dossier accompanying a request for authorisation in accordance with paragraph 11 of Part 2 of Schedule 3 (request for authorisation) to those Regulations must pay the fees mentioned in paragraph (2).
2
The fees referred to in paragraph (1) are —
a
the fee prescribed in paragraph 44 of Part 4 of Schedule 1 in connection with that amendment; and
b
in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29 and 31.
Applications for multiple variations
20
1
Unless paragraph (3) or (5) applies, a separate fee is payable in respect of each application to vary each term of a marketing authorization.
2
Unless paragraph (5) applies, a separate fee is payable in respect of each variation of each provision of a traditional herbal registration, manufacturing authorisation or licence applied for in any one application.
3
A separate fee is not payable for each application to vary a term of a marketing authorization which —
a
falls within the same type of group application; or
b
the licensing authority —
i
in consultation with other Member States concerned, have agreed, in accordance with Article 7(2)(b) of EC Regulation No. 1234/2008 , should be subject to the procedure for grouping of variations within the meaning of that Article; and
ii
have agreed fall, or should be treated as falling, within the same type of group application.
4
For the purposes of paragraph (3) the reference to a group application means an application which is a —
a
Minor Variation (Type IB) Group Application;
b
Major Variation (Type II) Group Application;
c
Major Variation (Type II) Complex Group Application; or
d
Major Variation (Type II) Extended Complex Group Application.
5
A separate fee is not payable for a variation which is wholly consequential upon another variation of a provision of a marketing authorization, traditional herbal registration, manufacturing authorisation or licence which is applied for in the same application.
6
In a case where a recommendation on the classification of a variation is made in accordance with Article 5 of EC Regulation No. 1234/2008, the fee payable for the application made in respect of that variation shall be the appropriate fee for the classification given to the variation or, as the case may be, the appropriate fee which arises as a consequence of the classification given to the variation.
7
In this regulation and Part 4 of Schedule 1 —
“Major Variation (Type II) Group Application” means an application for several variations to one marketing authorization and —
at least one of the variations is a major variation of type II;
subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008;
the variations do not include a variation —
of a kind referred to in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to EC Regulation No. 1234/2008;
which relates to a change which is referred to in paragraph 23 of Schedule 1 (Type II Complex Variation Application); or
of a marketing authorization so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 1 (Extended Type II Complex Variation Application); and
the variations may include one or more minor variations of type IA or one or more minor variations of type IB;
“Major Variation (Type II) Complex Group Application” means an application for several variations to one marketing authorization and —
at least one of the variations relates to one or more of the changes referred to in paragraph 23 of Schedule 1 (Type II Complex Variation Application);
subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008;
the variations do not include a variation of —
a kind referred to in paragraph 1 or paragraph 3 of Annex III to EC Regulation No. 1234/2008; or
a marketing authorization so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 1; and
the variations may include one or more minor variations of type IA or one or more minor variations of type IB or one or more major variations of type II;
“Major Variation (Type II) Extended Complex Group Application” means an application for several variations to one marketing authorization and —
at least one of the variations is a variation to a marketing authorization so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 1;
subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008;
the variations do not include a variation of a kind referred to in paragraph 1 of Annex III to EC Regulation No. 1234/2008; and
the variations may include minor variations of type IA, minor variations of type IB or other major variations of type II or a variation relating to a change referred to in paragraph 23(a), (b) or (c) of Schedule 1;
“major variation of type II” has the meaning given in Article 2(3) of EC Regulation No. 1234/2008;
“Minor Variation (Type IB) Group Application” means an application for several variations to one marketing authorization and —
at least one of the variations is a minor variation of type IB;
subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008;
the variations do not include —
a variation of a kind referred to in paragraph 1 or paragraph 2 of Annex III of EC Regulation No. 1234/2008; or
a major variation of type II; and
the variations may include one or more minor variations of type IA;
“minor variation of type 1A” has the meaning given in Article 2(2) of EC Regulation No. 1234/2008;
“minor variation of type 1B” has the meaning given in Article 2(5) of EC Regulation No. 1234/2008; and
“work sharing” means the worksharing procedure within the meaning of Article 20 of EC Regulation No. 1234/2008.
PART 6 Capital Fees for Assessment of Labels and Leaflets
Meaning of “set of proposed changes”
21
For the purposes of this Part and Part 5 of Schedule 1, a “set of proposed changes” means a number of proposed changes to the labelling or package leaflet of a medicinal product, where —
a
if there is more than one version of the labelling or package leaflet for that product, those changes all relate to the same version; and
b
those changes are submitted to the licensing authority at the same time.
Fees for assessment of a set of proposed changes to labels and leaflets
22
1
Unless paragraph (2) applies, where —
a
a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a United Kingdom marketing authorization (other than a parallel import licence) is submitted to the licensing authority in accordance with Article 61(3) of the 2001 Directive; or
b
a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a parallel import licence is submitted to the licensing authority,
the fee payable by the holder of that authorization or licence is the fee prescribed in Part 5 of Schedule 1 in connection with that change.
2
Paragraph (1) does not apply where a change to the labelling or package leaflet of a medicinal product is proposed in connection with an application for the variation of the marketing authorization for that product.
Time for payment of fees under regulation 22
23
All sums payable by way of fees under regulation 22(1) must be paid at the time when the proposed changes are submitted to the licensing authority.
PART 7 Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections
Fees for renewals of certain manufacturer’s licences
24
1
The fee payable by the applicant for an application to renew a manufacturer’s licence which falls within the description in paragraph (2) is £174.
2
The licence referred to in paragraph (1) is one —
a
which is solely for the manufacture of medicinal products the sale or supply of which does not require a marketing authorization or a product licence; and
b
to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies.
3
Where an inspection of a site is made in connection with the application referred to in paragraph (1) an inspection fee of £287 is also payable by the applicant.
Fees for renewals in terms which are not identical to the existing authorization, licence or registration
25
Where an applicant applies for renewal of a —
a
marketing authorization (other than a European Union marketing authorization);
b
traditional herbal registration;
c
manufacturer’s licence; or
d
wholesale dealer’s licence,
so as to contain provisions which are not identical to those in the authorization, registration or licence as in force at the date of the application, the fee payable under this Part is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had the applicant made a separate application for variation of that authorization, registration or licence in respect of each provision which is not identical.
PART 8 Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations
Fees for regulatory assistance for certain marketing authorizations
26
1
Where —
a
an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization for a medicinal product which has been subject to the procedures specified in paragraph (2); and
b
the United Kingdom is to provide regulatory assistance acting as reference Member State in relation to that application,
the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 1 in connection with that regulatory assistance.
2
The procedures referred to in paragraph (1) are —
a
the procedures laid down in Articles 7 and 7a of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and in Articles 17 and 18 of the 2001 Directive;
b
the procedures laid down in Article 9(4) of Directive 75/319/EEC and in Article 28 of the 2001 Directive;
c
the procedures laid down in Articles 10 to 14 of Directive 75/319/EEC and in Articles 29 to 34 of the 2001 Directive;
d
referral to the Committee for Proprietary Medicinal Products in accordance with Council Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology , if the opinion of the Committee in accordance with Article 4.1 of that Directive was given before 1st January 1995.
3
For the purposes of this regulation and Part 6 of Schedule 1, the United Kingdom provides regulatory assistance acting as reference Member State if —
a
the licensing authority prepares or updates an assessment report in respect of the medicinal product to which the renewal application relates in order to make it available to the competent authorities of another EEA State; and
b
an application to renew the marketing authorization relating to that product has been made in that other EEA State.
PART 9 Capital Fees for Inspections
Fees for inspections
27
1
Unless regulation 52 (revocations and savings) applies, a fee is payable in accordance with —
a
paragraphs 1 to 7 of Schedule 2 for any inspection of a site made in connection with an application for, or during the currency of, a marketing authorization, a traditional herbal registration, a clinical trial authorisation, a manufacturing authorisation, a manufacturer’s licence or a wholesale dealer’s licence, except for an inspection for which a fee is payable under regulations 24 or 30; and
b
paragraphs 1 and 8 of Schedule 2 for any inspection comprising an office-based evaluation and risk assessment of documentation but not involving inspection of a site, in connection with the monitoring of —
i
good manufacturing practice;
ii
good clinical practice;
iii
good pharmacovigilance practice; or
iv
good distribution practice.
2
Unless regulation 28 or 29 applies, the fee in paragraph (1) is payable by the holder of, or as the case may be, applicant for, the authorization, registration, authorisation or licence in relation to which the inspection is made.
Payer of inspection fee (contract laboratories and API manufacturing sites)
28
Where an inspection is made of a contract laboratory or a site used by an API manufacturer the fee is payable by the operator of that laboratory, or as the case may be, that API manufacturer.
Inspections in connection with multiple applications
29
1
Unless paragraph (4) applies, where an inspection is made outside the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product —
a
in more than one marketing authorization, clinical trial authorisation, traditional herbal registration; or
b
by more than one applicant for such an authorisation or licence,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by the holders of, or as the case may be, applicants for, the authorization, registration, authorisation, or licence.
2
In paragraph (1), the reference to an applicant for a clinical trial authorisation is a reference to a person who sends a valid notice of amendment as mentioned in regulation 19(1).
3
Where an inspection is made in the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product —
a
in more than one manufacturer’s licence or manufacturing authorisation; or
b
by more than one applicant for such a licence or authorisation,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by each applicant.
4
This regulation does not apply if the inspection is made of a contract laboratory or a site used by an API manufacturer.
Fees for inspections relating to good clinical practice in clinical trials
30
A fee in accordance with paragraph 2 of Schedule 2 is payable by a person in respect of an inspection of one or more sites for the purpose of ascertaining whether that person —
a
is —
i
conducting, or has conducted, a clinical trial; or
ii
performing, or has performed, the functions of a sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),
in accordance with good clinical practice, pursuant to regulation 28(1) (good clinical practice and protection of clinical trial subjects) of the Clinical Trials Regulations; or
b
has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the requirements of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations.
Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence
31
1
All sums payable by way of fees in respect of any inspection of a site in connection with an application for a wholesale dealer’s licence under regulation 27(1) must be paid at the time that application is made.
2
Except where paragraph (3) applies, the inspection fee payable as a consequence of paragraph (1) shall be the amount specified in paragraph 5(a) of Schedule 2.
3
In a case where —
a
the site to be inspected falls within the description specified in paragraph 7(1)(a) or (b) of Schedule 2; or
b
the total turnover in respect of sales by way of wholesale dealing in authorised medicinal products of the wholesale dealer does not exceed £35,000 (within the meaning given in paragraph 7(2) of that Schedule),
the inspection fee payable as a consequence of paragraph (1) shall be the amount specified in paragraph 5(b) of Schedule 2.
Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence
32
1
If the inspection in respect of an application for a wholesale dealer’s licence takes —
a
in the case where regulation 31(2) applies, more than 7 hours; or
b
in the case where regulation 31(3) applies, more than 3 hours and 30 minutes,
a further fee of the amount specified in paragraph 5(b) of Schedule 2 for each subsequent period of 3 hours and 30 minutes or less is payable by the applicant.
2
The fee payable under paragraph (1) must be paid within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.
3
The licensing authority shall refund the whole of the inspection fee paid where, after an inspection fee is paid as a consequence of regulation 31, the application for a wholesale dealer’s licence is withdrawn —
a
before a date on which the inspection is due to take place is arranged with or notified to the applicant; or
b
in the case where a date on which the inspection is due to take place is fixed, 15 or more days before the date on which that inspection is due to take place.
PART 10 Periodic Fees for Authorizations, Registrations, Licences and Authorisations
Periodic fees
33
1
Unless paragraphs (4), (5) or (6) or regulation 52 (revocations and savings) applies, the periodic fee must be paid for each fee period during which the marketing authorization, registration, authorisation or licence is in force, even if it is in force for only part of that fee period.
2
For the purposes of paragraph (1), marketing authorizations of a type referred to in Part 3 of Schedule 3 shall be treated as if they were one marketing authorization and only one periodic fee in respect of each relevant fee period is payable in connection with the holding of such authorizations.
3
The periodic fee is the appropriate fee prescribed in Part 3 of Schedule 3 and, for the purposes of that Part, Parts 1 and 2 of that Schedule have effect.
4
No periodic fee is payable in respect of the fee period during which a marketing authorization or a traditional herbal registration is first granted unless the authorization or registration is granted pursuant to —
a
a change of ownership application; or
b
an application for a marketing authorization or traditional herbal registration which —
i
is for a product for which an authorization or registration has expired;
ii
will contain identical provisions to those contained in the expired authorization or registration;
iii
is made by the person who held the expired authorization or registration; and
iv
is made no later than three months after the expiry of the authorization or registration referred to in paragraph (i),
and, in each case, a periodic fee has not been paid in respect of that fee period in connection with the expired marketing authorization or a traditional herbal registration.
5
An authorization, registration, authorisation or licence which is in force is treated for the purposes of this regulation as not being in force during any part of a fee period if —
a
at least three months before the commencement of that fee period, the holder of that authorization, registration, authorisation or licence has given written notice to the licensing authority indicating that he wishes it to cease to have effect before the commencement of that period; and
b
no products are sold, supplied or manufactured pursuant to that authorization, registration authorisation or licence within that fee period.
6
No periodic fee is payable in respect of the fee period during which a manufacturing authorisation, a manufacturer’s licence or wholesale dealer’s licence is first granted unless —
a
that authorisation or licence is granted pursuant to a change of ownership application; and
b
a periodic fee has not been paid in respect of that fee period in connection with the manufacturing authorisation or manufacturer’s licence or wholesale dealer’s licence which is mentioned in that application in the statement of intention to cease activities.
Periodic fees for clinical trial authorisations
34
1
Unless paragraph (3) applies, the holder of a clinical trial authorisation must pay the periodic fee for each fee period during which the authorisation is in force, even if the authorisation is in force for only part of that fee period.
2
The periodic fee is the fee prescribed in paragraph 16 of Part 3 of Schedule 3.
3
No periodic fee is payable in respect of the fee period during which the clinical trial to which the authorisation relates was authorised by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics) of the Clinical Trials Regulations .
PART 11 Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
Meaning of “good clinical practice accreditation scheme”
35
In this Part —
“good clinical practice accreditation scheme” means the non-statutory voluntary scheme of accreditation operated by the licensing authority in relation to Phase 1 trials which participants may join following satisfactory completion of a good clinical practice inspection; and
“Phase 1 trials” are clinical trials to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.
Fees for applications for membership and certificates
36
1
The fee payable by an applicant for membership of the good clinical practice accreditation scheme is £126.
2
The fee payable by an applicant for a certificate of membership of the good clinical practice accreditation scheme is £67.
PART 12 Capital Fee for a Person Appointed Hearing
Fee for a person appointed hearing
37
1
The fee payable by an applicant or holder of an authorization, licence, authorisation or certificate of registration or sponsor or investigator who gives notice, under any of the provisions specified in paragraph (2), of their wish to make further representations to the licensing authority or appear before or be heard by a person appointed by the licensing authority, is £10,000.
2
The specified provisions are —
a
section 21(11) (licence under Part I of the Act where appropriate committee are consulted), 22(3) (licence under Part I of the Act where appropriate committee are not consulted or have been consulted but have not given a provisional opinion) or 27(3) (licence of right) of the Act, and paragraph 5 (product licence) or paragraph 6 (licence under Part 2 of the Act other than a product licence) of Schedule 2 to the Act ;
b
paragraph 3 of Schedule 5 (authorisation to conduct a clinical trial or amendment to clinical trial authorisation) and paragraph 4 of Schedule 8 (manufacturing authorisation) to the Clinical Trials Regulations ;
c
paragraph 12 (traditional herbal registration), paragraph 17 (variation of registration) or paragraph 20 (decision to refer application to the Committee) of Schedule 2 to the Herbal Regulations; or
d
paragraph 11 (marketing authorizations) or paragraph 16 (Type II variation applications) of Schedule 2 to the Marketing Authorisation Regulations .
3
The licensing authority will refund to that person —
a
60% of that fee if the person withdraws the notice two weeks before the commencement of the hearing before the person appointed;
b
100% of that fee if, in respect of the hearing before a person appointed, the decision notified by the licensing authority is —
i
not to revoke, vary, suspend or terminate, as the case may be, the authorization, licence, authorisation or certificate of registration; or
ii
to grant or renew, as the case may be, the authorization, licence, authorisation or certificate of registration.
Time for payment under regulation 37
38
The fee prescribed in regulation 37 is payable at the time the notice is given.
PART 13 Administration
Payment of fees to Ministers
39
Any sum payable under these Regulations must be paid to one of the Ministers.
Time for payment of capital fees in connection with applications or inspections
40
1
Subject to provisions specified in paragraph (2), all sums payable by way of capital fees —
a
under these Regulations, except where sub-paragraph (b) applies in connection with any application, must be paid at the time of the application; and
b
in respect of inspections made either in connection with an application for, or during the currency of, an authorization, licence or certificate must be paid within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.
2
The specified provisions are —
a
regulation 10 (pre-application meetings);
b
regulation 16 (regulatory assistance);
c
regulation 22 (change to labels and leaflets);
d
regulation 31 (inspections in respect of wholesale dealer’s licence);
e
regulation 37 (person appointed hearings); and
f
regulation 41 (small companies).
Time for payment of capital fees – applications made by small companies
41
1
Schedule 4 shall have effect with respect to the capital fee payable in connection with an application made by or on behalf of a small company.
2
For the purpose of these Regulations, a company is a small company if, for the financial year before that in which the application is made, the amount of its turnover for the financial year is not more than the amount for the time being specified under the heading “Small company” in section 382(3) (qualification of company as small) of the Companies Act 2006 and the condition in paragraph (3)(a) or (b) is met.
3
The conditions for the purposes of paragraph (2) are —
a
the company’s balance sheet total (as defined in section 382(5) of that Act) is not more than the amount for the time being specified under the heading “Small company” in section 382(3) of that Act; or
b
the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified under the heading “Small company” in section 382(3) of that Act.
Payment of fees in respect of a traditional herbal registration
42
1
Where an application is made for the grant of a traditional herbal registration —
a
in accordance with regulation 5 of the Herbal Regulations;
b
on the grounds specified in paragraph (2); and
c
in respect of a medicinal product which falls within the description in paragraph (3),
the fee payable under regulation 12 shall be refunded or, if it has not been paid, shall be waived.
2
For the purposes of paragraph (1), the specified grounds are —
a
that the marketing authorization in respect of the medicinal product in question; or
b
in the case of a corresponding product the marketing authorization relating to product Y (as defined in paragraph (4)),
is to be revoked.
3
A medicinal product falls within this paragraph if —
a
a marketing authorization held by the applicant was granted under the Marketing Authorisation Regulations in respect of that medicinal product; or
b
that medicinal product is a corresponding product.
4
For the purposes of paragraph (3), a corresponding product is a product which is characterised by having —
a
the same active ingredients, irrespective of the excipients used or reduction in the number or quantity of active ingredients;
b
the same or similar intended purpose, equivalent strength and posology; and
c
the same or similar route of administration,
as a medicinal product (“product Y”) in respect of which a marketing authorization held by the applicant was granted under the Marketing Authorisation Regulations.
5
Where the licensing authority determines that the marketing authorizations in respect of the medicinal product in question or the marketing authorization in respect of product Y should not be revoked, the fee payable under regulation 12 which has been refunded or waived shall become payable within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.
Time for payment of periodic fees
43
All periodic fees must be paid on the first day of the fee period to which they relate.
Penalty fees for late payment of periodic fees
44
1
Subject to paragraph (2), if a person has failed to pay a periodic fee at the time it should have been paid under regulation 43, a penalty fee is payable by that person.
2
A penalty fee is payable only if, after a period of 60 days commencing on the date of the written notice (“the notice”) issued by the licensing authority requiring payment of that fee, the fee remains unpaid.
3
Unless regulation 45 applies, the penalty fee is —
a
£100 where the total periodic fee unpaid by a person after a period of 60 days commencing on the date of the notice exceeds £200; or
b
£50 where the total periodic fee unpaid by a person after such period does not exceed £200.
4
In paragraph (3), the “total periodic fee” means the aggregate of all the periodic fees payable by a person in connection with all the authorizations, registrations, authorisations or licences held by that person.
Daily penalty fees for late payment of periodic fees
45
If the periodic fee and penalty fee under regulation 44 (“the outstanding amount”) have not been paid within a period of 90 days commencing on the date of the written notice issued by the licensing authority, the amount of penalty fee payable shall be the amount specified in regulation 44(3) plus £5 for each day of the period which —
a
begins with the day 90 days from the date of the written notice; and
b
ends with the day before that on which payment of the outstanding amount is actually made.
Refund or waiver of fees under regulation 44 or 45
46
The licensing authority may refund or waive payment of the penalty fee, or reduce the amount payable, where it is satisfied that the holder of the authorization, registration, authorisation or licence was not responsible for the failure to pay the periodic fee within the period specified in regulation 44(2) or 45.
Adjustment, waiver, reduction or refund of fees
47
1
If after a capital or periodic fee is paid it becomes apparent that —
a
a lesser fee should have been paid, the excess shall be refunded to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned; or
b
a higher fee should have been paid, the balance due shall be payable within a period of 14 days commencing on the date of the written notice issued by the licensing authority to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned requiring payment of that balance.
2
The licensing authority shall, to the extent provided in Schedule 5 in relation to capital fees or in Schedule 6 in relation to periodic fees —
a
adjust, waive payment of or reduce any fee or part of a fee otherwise payable under these Regulations; or
b
refund the whole or part of any fee already paid.
Suspension of licences and authorisations
48
1
Where any sum due by way of, or on account of, any fee or any part thereof payable under these Regulations remains unpaid by the holder of a —
a
product licence or a product licence of right;
b
manufacturer’s licence;
c
manufacturer’s authorisation; or
d
wholesale dealer’s licence,
the licensing authority may serve a written notice on the holder requiring payment of the sum unpaid.
2
If after a period of one month commencing on the date of service of the notice referred to in paragraph (1), or such longer period as the licensing authority may allow, the said sum remains unpaid, the licensing authority may forthwith suspend the licence or, as the case may be, the authorisation until such sum has been paid.
Civil proceedings to recover unpaid fees
49
All unpaid sums due by way of, or on account of, any fees payable under these Regulations shall be recoverable as debts due to the Crown.
PART 14
Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
50
1
The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 are amended as follows.
2
In regulation 14 (fees for variation of certificates) —
a
in paragraph (1)(a), for “£132” substitute “£133”;
b
in paragraph (1)(b)(i), for “£132” substitute “£133”;
c
in paragraph (1)(b)(ii), for “£66” substitute “£67”;
d
in paragraph (2)(a), for “£260” substitute “£263”;
e
in paragraph (2)(b)(i), for “£260” substitute “£263”;
f
in paragraph (2)(b)(ii), for “£260” substitute “£263”;
g
in paragraph 2(b)(iii), for “£132” substitute “£133”; and
h
in paragraph 2(b)(iv), for “£66” substitute “£67”.
3
In regulation 15 (fees payable by holders of certificates), in paragraph (1), for “£23” substitute “£24”.
4
In the table in Schedule 2 (fees for applications for the grant of certificates of registration) —
a
in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks) —
i
for “£171” substitute “£172”;
ii
for “£512” substitute “£517”;
iii
for “£537” substitute “£542”; and
iv
for “£846” substitute “£854”.
b
in column (3) (fees for other applications) —
i
for “£421” substitute “£425”;
ii
for “£754” substitute “£761”;
iii
for “£683” substitute “£690”; and
iv
for “£1,107” substitute “£1,118”.
5
In Schedule 2A (fees for assistance in obtaining certificates of registration in other EEA States) , in paragraph 2 —
a
in sub-paragraph (a), for “£307” substitute “£310”; and
b
in sub-paragraph (b), for “£401” substitute “£405”.
PART 15 Consequential Amendments
Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
51
1
The Medicines for Human Use (Clinical Trials) Regulations 2004 are amended as follows.
2
In regulation 17(2)(b)(ii), for “Medicines (Products for Human Use – Fees) Regulations 1995” substitute “Medicines (Products for Human Use) (Fees) Regulations 2010”.
3
In regulation 24(10) , in the definition of “any relevant fee”, for “Medicines (Products for Human Use – Fees) Regulations 1995” substitute “Medicines (Products for Human Use) (Fees) Regulations 2010”.
4
In regulation 38(3)(b), for “Medicines (Products for Human Use – Fees) Regulations 1995” substitute “Medicines (Products for Human Use) (Fees) Regulations 2010”.
5
In regulation 44(8) , in the definition of “any relevant fee”, for “Medicines (Products for Human Use – Fees) Regulations 1995” substitute “Medicines (Products for Human Use) (Fees) Regulations 2010”.
PART 16 Revocations and Savings
Revocations and savings
52
1
Subject to paragraphs (2) to (4), the Medicines (Products for Human Use) (Fees) Regulations 2009 (“the 2009 Regulations ”) are revoked.
2
The savings introduced by regulation 51(2) and (3) of the 2009 Regulations shall continue to apply as if those paragraphs of that regulation had not been revoked.
3
The 2009 Regulations shall continue to apply as if they had not been revoked —
a
in relation to capital fees payable under the 2009 Regulations in respect of any application or inspection made before the date on which these Regulations come into force; and
b
to any periodic fee payable under the 2009 Regulations in relation to a fee period ending before the date on which these Regulations come into force.
4
The revocation of the 2009 Regulations shall not affect any proceedings constituted under those Regulations for the recovery of any fees due as debts to the Crown and for the purposes of those proceedings, the 2009 Regulations shall continue to apply as if they had not been revoked.
Signed by authority of the Secretary of State for Health
Mike O’Brien
Minister of State,
Department of Health
22nd February 2010
Michael McGimpsey
Minister for Health, Social Services and Public Safety
26th February 2010
Tony Cunningham
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
25th February 2010


type: legislation

jurisdiction: UK

text:
Citation and interpretation
1
1
This Order may be cited as the Planning Act 2008 (Commencement No.4 and Saving) Order 2010.
2
In this Order, “ the Act ” means the Planning Act 2008.
Provisions coming into force on 1st March 2010 in relation to England, Wales, Scotland and Northern Ireland
2
Section 36 of and Schedule 2 to the Act (amendments consequential on development consent regime) shall come into force on 1st March 2010.
Provisions coming into force on 1st March 2010 in relation to England and Wales and, to the extent specified in section 240(4) of the Act, to Scotland
3
The following provisions of the Act (so far as they are not yet in force) shall come into force, in relation to England and Wales and, to the extent specified in section 240(4) of the Act, to Scotland, on 1st March 2010 —
a
section 14(1) (a) to (l) and (2) to (7);
b
section 21;
c
sections 31 to 35;
d
sections 55 and 60 to 119, and Schedules 3 and 4;
e
sections 120 to 121 and Schedule 5;
f
sections 122 to 132 and section 134;
g
sections 135 to 138;
h
sections 150 to 152;
i
sections 154 to 159;
j
sections 160 to 173; and
k
section 174.
Provisions coming into force on 1st March 2010 in relation to England and Wales
4
The following provisions of the Act (so far as they are not yet in force) shall come into force, in relation to England and Wales, on 1st March 2010 —
a
sections 15 to 20;
b
sections 22 to 26;
c
section 118;
d
section 133;
e
sections 139 to 149; and
f
section 175.
Provisions coming into force on 1st March 2010 in relation to Scotland
5
Section 176 (so far as not yet in force) shall come into force, in relation to Scotland, on 1st March 2010.
Saving
6
The provisions of the Act brought into force by this Order shall have no effect in relation to an application made before 1st March 2010 for any such consent or authorisation as is mentioned in section 33 of the Act (effect of requirement for development consent on other consent regimes) .
Signed by authority of the Secretary of State for Communities and Local Government
Ian Austin
Parliamentary Under Secretary of State
Department for Communities and Local Government
25th January 2010


text:
Citation and commencement
1
1
These Regulations may be cited as the Social Security (Miscellaneous Amendments) (No. 5) Regulations 2010.
2
Subject to paragraph (3), these Regulations come into force on 1st November 2010.
3
Regulations 2(3)(a), 3 and 4(5)(a), so far as they relate to a particular beneficiary, come into force on the first day of the first benefit week to commence for that beneficiary on or after 1st November 2010.
4
In this regulation “benefit week” has the same meaning —
a
for income support, as in regulation 2(1) (interpretation) of the Income Support (General) Regulations 1987 ;
b
for jobseeker’s allowance, as in regulation 1(3) (citation, commencement and interpretation) of the Jobseeker’s Allowance Regulations 1996 ; and
c
for employment and support allowance, as in regulation 2(1) (interpretation) of the Employment and Support Allowance Regulations 2008 .
Amendments to the Income Support (General) Regulations 1987
2
1
The Income Support (General) Regulations 1987 are amended as follows.
2
In Schedule 1B (prescribed categories of person) —
a
in paragraph 7(c) , for “that Act” substitute “the Contributions and Benefits Act”;
b
in paragraph 14(b) , omit “seven weeks after the date on which her pregnancy ends where the expected week of confinement begins prior to 6th April 2003 or” and “where the expected week of confinement begins on or after 6th April 2003”.
3
In Schedule 9 (sums to be disregarded in the calculation of income other than earnings) —
a
in paragraph 5B , after sub-paragraph (2) add —
3
Any increase in respect of a dependent child or dependent young person under section 80 or 90 of the Contributions and Benefits Act where —
a
the claimant has a child or young person who is a member of the claimant’s family for the purposes of the claimant’s claim for income support, and
b
the claimant, or that claimant’s partner, has been awarded a child tax credit.
;
b
for paragraph 26 , substitute —
26
Any payment made to the claimant with whom a person is accommodated by virtue of arrangements made —
a
by a local authority under —
i
section 23(2)(a) of the Children Act 1989 (provision of accommodation and maintenance for a child whom they are looking after),
ii
section 26 of the Children (Scotland) Act 1995 (manner of provision of accommodation to child looked after by local authority), or
iii
regulations 33 or 51 of the Looked After Children (Scotland) Regulations 2009 (fostering and kinship care allowances and fostering allowances); or
b
by a voluntary organisation under section 59(1)(a) of the Children Act 1989 (provision of accommodation by voluntary organisations).
;
c
in paragraph 28 —
i
in sub-paragraph (1)(c), after “section” insert “22, ”;
ii
in sub-paragraph (2), before “29” insert “22 or”.
Amendment to the Social Security (Claims and Payments) Regulations 1987
3
In paragraph 1 of Schedule 9A (deductions of mortgage interest from benefit and payment to qualifying lenders) to the Social Security (Claims and Payments) Regulations 1987 , in the definition of “relevant benefits” —
a
after paragraph (c), insert —
ca
contribution-based jobseeker’s allowance where —
i
both income-based jobseeker’s allowance and contribution-based jobseeker’s allowance are in payment, and
ii
the income-based jobseeker’s allowance alone is insufficient for the purposes of this Schedule;
;
b
after paragraph (e), insert —
f
contributory employment and support allowance where —
i
both income-related employment and support allowance and contributory employment and support allowance are in payment, and
ii
the income-related employment and support allowance alone is insufficient for the purposes of this Schedule;
.
Amendments to the Jobseeker’s Allowance Regulations 1996
4
1
The Jobseeker’s Allowance Regulations 1996 are amended as follows.
2
In Schedule A1 (categories of members of a joint-claim couple who are not required to satisfy the conditions in section 1(2B)(b)), subject to paragraph (3) below —
a
the following provisions are revoked —
i
paragraph 6(a) and (b) (member incapable of work),
ii
paragraph 9 (disabled students),
iii
paragraph 10 (deaf students), and
iv
paragraph 11 (blind members);
b
for the heading preceding paragraph 6 substitute “Member treated as capable of work, or member entitled to statutory sick pay”;
c
in paragraph 6(c), for “that Act”, substitute “the Benefits Act”.
3
A provision revoked or amended by paragraph (2) continues to have effect in relation to a joint-claim couple as if that revocation or amendment had not been made where, immediately before 1st November 2010 —
a
the couple were entitled to a jobseeker’s allowance, and
b
that provision applied to a member of that couple.
4
Paragraph (3) ceases to apply to a joint-claim couple upon termination of the jobseeker’s allowance award that they were entitled to immediately before 1st November 2010.
5
In Schedule 7 (sums to be disregarded in the calculation of income other than earnings) —
a
in paragraph 6B , after sub-paragraph (2) add —
3
Any increase in respect of a dependent child or dependent young person under section 80 or 90 of the Benefits Act where —
a
the claimant has a child or young person who is a member of the claimant’s family for the purposes of the claimant’s claim for income-based jobseeker’s allowance, and
b
the claimant, or that claimant’s partner, has been awarded a child tax credit.
;
b
for paragraph 27 , substitute —
27
Any payment made to the claimant with whom a person is accommodated by virtue of arrangements made —
a
by a local authority under —
i
section 23(2)(a) of the Children Act 1989 (provision of accommodation and maintenance for a child whom they are looking after),
ii
section 26 of the Children (Scotland) Act 1995 (manner of provision of accommodation to child looked after by local authority), or
iii
regulations 33 or 51 of the Looked After Children (Scotland) Regulations 2009 (fostering and kinship care allowances and fostering allowances); or
b
by a voluntary organisation under section 59(1)(a) of the Children Act 1989 (provision of accommodation by voluntary organisations).
;
c
in paragraph 29 —
i
in sub-paragraph (1)(c), after “section” insert “22, ”;
ii
in sub-paragraph (2), before “29” insert “22 or”.
Amendments to the Employment Protection (Recoupment of Jobseeker’s Allowance and Income Support) Regulations 1996
5
In the Employment Protection (Recoupment of Jobseeker’s Allowance and Income Support) Regulations 1996 in —
a
regulation 2(1) (interpretation) in the definition of “recoupable benefit”;
b
regulation 4(1) and (8) (duties of the employment tribunals and of the secretary of the tribunals in respect of monetary awards) ;
c
regulation 8(1), (2)(b) and (3)(b) (recoupment of benefit); and
d
regulation 10(1) and (2) (provisions relating to determination of amount paid by way of or paid as on account of benefit),
after “allowance” insert “, income-related employment and support allowance”.
Amendment to the State Pension Credit Regulations 2002
6
In regulation 17B(4)(b) (earnings of self-employed earners) of the State Pension Credit Regulations 2002 —
a
for “for paragraph (2), the following provision shall have effect” substitute “the following paragraph shall be added after paragraph (1)”.
b
for sub-paragraph (b) of the new paragraph (2) to be added to regulation 12 (earnings of self-employed earners) of the Social Security Benefits (Computation of Earnings) Regulations 1996 , substitute —
b
any payment made by a local authority to a claimant with whom a person is accommodated by virtue of arrangements made under —
i
section 23(2)(a) of the Children Act 1989 (provision of accommodation and maintenance for a child whom they are looking after),
ii
section 26 of the Children (Scotland) Act 1995 (manner of provision of accommodation to child looked after by local authority), or
iii
regulations 33 or 51 of the Looked After Children (Scotland) Regulations 2009 (fostering and kinship care allowances and fostering allowances);
.
Amendments to the Housing Benefit Regulations 2006
7
1
The Housing Benefit Regulations 2006 are amended as follows.
2
In regulation 28(8)(k) (treatment of child care charges) —
a
after “by a foster parent” insert “or kinship carer”;
b
for “Fostering of Children (Scotland) Regulations 1996” substitute “Looked After Children (Scotland) Regulations 2009”;
c
after “is fostering” insert “or kinship carer is looking after”.
3
In Schedule 5 (sums to be disregarded in the calculation of income other than earnings) for paragraph 26 substitute —
26
Any payment made to the claimant with whom a person is accommodated by virtue of arrangements made —
a
by a local authority under —
i
section 23(2)(a) of the Children Act 1989 (provision of accommodation and maintenance for a child whom they are looking after),
ii
section 26 of the Children (Scotland) Act 1995 (manner of provision of accommodation to child looked after by local authority), or
iii
regulations 33 or 51 of the Looked After Children (Scotland) Regulations 2009 (fostering and kinship care allowances and fostering allowances); or
b
by a voluntary organisation under section 59(1)(a) of the Children Act 1989 (provision of accommodation by voluntary organisations).
.
4
In Schedule 5, paragraph 28 and Schedule 6 (capital to be disregarded), paragraph 19 before “29” insert “22,”.
Amendments to the Housing Benefit (Persons who have attained the qualifying age for state pension credit) Regulations 2006
8
1
The Housing Benefit (Persons who have attained the qualifying age for state pension credit) Regulations 2006 are amended as follows.
2
In regulation 31(8)(k) (treatment of child care charges) —
a
after “by a foster parent” insert “or kinship carer”;
b
for “Fostering of Children (Scotland) Regulations 1996” substitute “Looked After Children (Scotland) Regulations 2009”;
c
after “is fostering” insert “or kinship carer is looking after”.
3
For regulation 38(2)(b)(ii) (earnings of self-employed earners), substitute —
ii
with whom a local authority foster a child under the Looked After Children (Scotland) Regulations 2009 or who is a kinship carer under those Regulations;
.
Amendments to the Council Tax Benefit Regulations 2006
9
1
The Council Tax Benefit Regulations 2006 are amended as follows.
2
In regulation 18(8)(k) (treatment of child care charges) —
a
after “by a foster parent” insert “or kinship carer”;
b
for “Fostering of Children (Scotland) Regulations 1996” substitute “Looked After Children (Scotland) Regulations 2009”;
c
after “is fostering” insert “or kinship carer is looking after”.
3
In Schedule 4 (sums to be disregarded in the calculation of income other than earnings) for paragraph 27 substitute —
27
Any payment made to the claimant with whom a person is accommodated by virtue of arrangements made —
a
by a local authority under —
i
section 23(2)(a) of the Children Act 1989 (provision of accommodation and maintenance for a child whom they are looking after),
ii
section 26 of the Children (Scotland) Act 1995 (manner of provision of accommodation to child looked after by local authority), or
iii
regulations 33 or 51 of the Looked After Children (Scotland) Regulations 2009 (fostering and kinship care allowances and fostering allowances); or
b
by a voluntary organisation under section 59(1)(a) of the Children Act 1989 (provision of accommodation by voluntary organisations).
.
4
In Schedule 4, paragraph 29 and Schedule 5 (capital to be disregarded), paragraph 19 before “29” insert “22,”.
Amendments to the Council Tax Benefit (Persons who have attained the qualifying age for state pension credit) Regulations 2006
10
1
The Council Tax Benefit (Persons who have attained the qualifying age for state pension credit) Regulations 2006 are amended as follows.
2
In regulation 21(8)(k) (treatment of child care charges) —
a
after “by a foster parent” insert “or kinship carer”;
b
for “Fostering of Children (Scotland) Regulations 1996” substitute “Looked After Children (Scotland) Regulations 2009”;
c
after “is fostering” insert “or kinship carer is looking after”.
3
For regulation 28(2)(b)(ii) (earnings of self-employed earners), substitute —
ii
with whom a local authority foster a child under the Looked After Children (Scotland) Regulations 2009 or who is a kinship carer under those Regulations;
.
Amendments to the Employment and Support Allowance Regulations 2008
11
1
The Employment and Support Allowance Regulations 2008 are amended as follows.
2
In regulation 106 (notional income – deprivation and income on application), after paragraph (2)(ga) insert —
gb
any sum to which regulation 137(4A) (treatment of student loans) applies;
.
3
In regulation 137 (treatment of student loans) —
a
in paragraph (4)(b), before “the student” insert “subject to paragraph (4A)”;
b
after paragraph (4) insert —
4A
A student is not to be treated as possessing any part of a student loan which has not been paid to that student in respect of an academic year where the educational institution at which the student was attending a course has confirmed in writing that the student has suspended attendance at the course due to a health condition or disability that renders the student incapable of continuing that course.
.
4
In Schedule 8 (sums to be disregarded in the calculation of income other than earnings) —
a
for paragraph 28 substitute —
28
Any payment made to the claimant with whom a person is accommodated by virtue of arrangements made —
a
by a local authority under —
i
section 23(2)(a) of the Children Act 1989 (provision of accommodation and maintenance for a child whom they are looking after), or
ii
section 26 of the Children (Scotland) Act 1995 (manner of provision of accommodation to child looked after by local authority), or
iii
regulations 33 or 51 of the Looked After Children (Scotland) Regulations 2009 (fostering and kinship care allowances and fostering allowances); or
b
by a voluntary organisation under section 59(1)(a) of the 1989 Act (provision of accommodation by voluntary organisations).
;
b
in paragraph 30(1)(c) before “29” insert “22,”;
c
in paragraph 30(2) before “29” insert “22 or”.
Amendment to the Social Security (Incapacity Benefit Work-focused Interviews) Regulations 2008
12
In regulation 9 (consequences of failure to take part in a work-focused interview) of the Social Security (Incapacity Benefit Work-focused Interviews) Regulations 2008 —
a
in paragraph (1)(a), before “50%”; and
b
in paragraph (1)(b) and (12)(c), after “by”,
insert “an amount equivalent to”.
Signed by authority of the Secretary of State for Work and Pensions.
Chris Grayling
Minister of State
Department for Work and Pensions
4th October 2010


text:
1
This Order may be cited as the Police and Justice Act 2006 (Commencement No. 13) Order 2010.
2
The following provisions of the Police and Justice Act 2006 shall come into force on 15th March 2010 —
a
section 2 (amendments to the Police Act 1996) in so far as it relates to paragraph 30 of Schedule 2 (amendments to the Police Act 1996);
b
paragraph 30 of Schedule 2 (arrangements for obtaining the views of the community on policing).
David Hanson
Minister of State
Home Office
22nd February 2010


text:
PART 1 Introduction
Title and commencement
1
These Regulations may be cited as the Marketing of Fruit Plant Material Regulations 2010 and come into force on 17th September 2010.
Interpretation
2
1
In these Regulations —
“the appropriate authority” means —
in relation to England, the Secretary of State,
in relation to Wales, the Welsh Ministers,
in relation to Scotland, the Scottish Ministers,
in relation to Northern Ireland, any Northern Ireland Department;
“Council Directive 2008/90/ EC ” means Council Directive 2008/90/EC on the marketing of fruit plant propagating material and fruit plants intended for fruit production ;
“Directive 93/48/ EEC ” means Commission Directive 93/48/EEC setting out the schedule indicating the conditions to be met by fruit plant propagating material and fruit plants intended for fruit production, pursuant to Council Directive 92/34/EEC ;
“inspector” means a person appointed under regulation 19 ;
“plant breeders’ rights” mean rights granted in accordance with Part 1 of the Plant Varieties Act 1997 or Council Regulation (EC) No 2100/94 on Community plant variety rights ;
“plant material” means the plants and materials described in regulation 3(1) and (2);
“producer” means any person involved professionally in the production or reproduction of plant material;
“supplier” means any producer or any person involved professionally in the marketing, preservation or treatment of plant material; and, from 30th September 2012, includes any person involved professionally in the importation of plant material.
2
In these Regulations, “supplier’s list” means a written list kept by a supplier containing —
a
the name of each variety marketed by the supplier and, where appropriate, its commonly known synonyms;
b
the description of those varieties having regard to the characteristics specified in the Annex to Commission Directive 93/79/EEC setting out additional implementing provisions for lists of varieties of fruit plant propagating material and fruit plants, as kept by suppliers under Council Directive 92/34/EEC ; and
c
in the case of a written list kept by a producer —
i
indications as to the maintenance of those varieties and the propagation system applied; and
ii
any indications as to how those varieties differ from the other varieties that they most closely resemble.
3
Any other expressions used in these Regulations that are also used in Council Directive 2008/90/EC have the same meaning in these Regulations as they have in that Directive.
Application
3
1
These Regulations apply in relation to fruit plants and propagating material of the genera and species listed in Schedule 1 and their hybrids.
2
They also apply in relation to parts of plants, including rootstocks, of other genera or species and their hybrids if material from fruit plants listed in Schedule 1 (or any hybrid of such fruit plants) is, or is to be, grafted on to them.
3
These Regulations do not apply in relation to plant material intended for export to third countries, if that plant material is identified as such and kept sufficiently isolated.
4
These Regulations do not apply to small producers all of whose production and sales of plant material is intended for final use by persons on the local market who are not involved professionally in plant production.
Marketing of plant material for trials etc.
4
1
These Regulations do not apply to the marketing of plant material intended for —
a
trials or scientific purposes,
b
selection work, or
c
measures aimed at the conservation of genetic diversity,
if the plant material is marketed in accordance with an authorisation granted by an inspector.
2
An authorisation —
a
must be in writing;
b
may be amended, suspended or revoked by notice; and
c
may be subject to such conditions as the inspector considers necessary.
Notices
5
Any notice under these Regulations must be in writing, may be subject to conditions and may be amended, suspended or revoked by notice in writing at any time.
PART 2 Accreditation and registration
Accreditation of producers
6
1
A producer must not market plant material unless accredited by the appropriate authority to do so.
2
The appropriate authority must accredit a producer if satisfied that the producer will comply with the requirements of regulations 17 and 18 .
3
A producer is accredited for the purposes of this regulation if, immediately before the coming into force of these Regulations, that producer was accredited under —
a
regulation 11 of the Marketing of Fruit Plant Material Regulations 1995 ; or
b
regulation 11 of the Marketing of Fruit Plant Material Regulations (Northern Ireland) 1995 .
4
This regulation ceases to have effect on 30th September 2012.
Registration
7
1
From 30th September 2012, a person must not be involved professionally in the importation, marketing, production or reproduction of plant material unless registered by the appropriate authority.
2
The appropriate authority must register a person involved professionally in the importation, marketing, production or reproduction of plant material if satisfied that the person will comply with the provisions of these Regulations.
3
A producer who, immediately before 30th September 2012, is accredited by the appropriate authority under regulation 6 is registered for the purposes of this regulation.
4
This regulation does not apply to persons involved only in the marketing of plant material to non-professional final consumers.
Revocation etc.
8
1
The appropriate authority may, by notice, revoke or suspend an accreditation under regulation 6 or a registration under regulation 7 if satisfied that the producer or registered person has failed to comply with any provision of these Regulations.
2
Unless the appropriate authority otherwise directs, a revocation or suspension under this regulation has immediate effect and continues in effect unless the accreditation or registration is reinstated.
Appeals
9
1
A person aggrieved by a decision of the appropriate authority under regulation 6(2) , 7(2) or 8 may appeal against the decision to a person appointed for the purpose by the appropriate authority in accordance with this regulation.
2
The appointed person must consider the appeal and any representations made by the appropriate authority and report in writing, with a recommended course of action, to the appropriate authority.
3
The appropriate authority must then reach a decision and notify the appellant, together with the reasons for it.
Registration of varieties
10
Schedule 2 makes provision for the registration of varieties of fruit plant.
PART 3 Marketing of plant material
Varieties that may be marketed
11
1
From 30th September 2012, a supplier must not market any plant material unless it is of a variety that is —
a
subject to a grant of plant breeders’ rights in any member State or is the subject of an application for such rights;
b
registered in accordance with Schedule 2 or is the subject of an application for such registration;
c
registered in any other member State in accordance with Article 7(2)(c) of Council Directive 2008/90/EC or is the subject of an application for such registration; or
d
included in the supplier’s list and —
i
has no intrinsic value for commercial crop production; or
ii
is marketed by the supplier prior to 30th September 2012.
2
A supplier who markets plant material in accordance with paragraph (1)(d)(i) must ensure that it is accompanied by a document stating that it is marketed in accordance with the second paragraph of Article 7(2) of Council Directive 2008/90/EC , or it is labelled to that effect.
Quality requirements for plant material
12
A supplier must not market any plant material unless —
a
it is substantially free on visual inspection from any organism or disease listed in the Annex to Directive 93/48/EEC and any other organism or disease that impairs its quality or reduces its usefulness as plant material;
b
it is substantially free from any defects likely to impair its usefulness as plant material;
c
it has adequate identity and purity relative to its genus or its species and (if it has one) its variety; and
d
it is in lots of sufficiently homogeneous composition and origin.
References to plant material
13
1
A supplier must not —
a
market a variety of plant material that is the subject of an application for a grant of plant breeders’ rights other than by reference to the breeder’s reference or proposed name of the variety;
b
from 30th September 2012 —
i
market a variety that is registered in accordance with Schedule 2, or registered in another member State in accordance with Article 7(2)(c) of Council Directive 2008/90/EC , other than by reference to its registered name;
ii
market a variety that is the subject of an application for such registration other than by reference to the breeders’ reference or the proposed name of the variety; or
c
market any other variety of plant material other than by reference to the information contained in the supplier’s list.
2
A supplier who markets rootstocks that do not belong to a variety must do so by reference to the appropriate species or interspecific hybrid.
Accompanying documentation
14
1
A supplier must not market plant material unless it is accompanied by a document that contains the information in Part 1 of Schedule 3.
2
Where plant material is accompanied by a plant passport issued in accordance with Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community , that plant passport may constitute the document in paragraph (1) if it is accompanied by the information in Part 2 of Schedule 3.
3
This regulation does not apply to the retail supply of plant material to a non-professional final consumer if that material is accompanied by a document containing appropriate product information.
Marketing of citrus plant material
15
A producer must not market any plant material of the genus Citrus unless —
a
it is derived from initial material which has been checked and found to show no symptoms of the viruses, virus-like organisms and diseases listed in the Annex to Directive 93/48/EEC in respect of Citrus and which has been tested individually using appropriate methods and found to be free from such viruses, virus-like organisms and diseases;
b
it has been checked and found to be substantially free from such viruses, virus-like organisms and diseases since the beginning of the last cycle of vegetation; and
c
in the case of grafting, it has been grafted on to rootstocks other than those susceptible to viroids.
PART 4 Additional requirements
Measures to be taken by producers
16
A producer must —
a
treat or, where appropriate, remove any plant material that shows visible signs or symptoms of any of the organisms or diseases referred to in regulation 12(a) ; and
b
keep plant material in lots of homogeneous composition and origin during growing and lifting or removal from parent material.
Monitoring of production process
17
A producer must —
a
identify and monitor critical points in the production process that influence the quality of plant material;
b
take samples of plant material for analysis in a laboratory, where necessary, to ensure compliance with these Regulations; and
c
ensure that lots of propagating material remain separately identifiable during production.
Record-keeping
18
1
A supplier must, as soon as reasonably practicable, make a record of —
a
all sales and purchases of plant material;
b
all deliveries of plant material to and from the supplier’s premises; and
c
the composition and origin of any plant material of different origins mixed by the supplier during packaging, storage or transport or at delivery.
2
A producer must, as soon as reasonably practicable, make a record of —
a
all plant material under production on the producer’s premises;
b
all occurrences on the producer’s premises of any organisms or diseases referred to in regulation 12(a) and on any measures taken in relation to such occurrences; and
c
all monitoring undertaken for the purposes of regulation 17(a) .
3
The records referred to in this regulation must be kept for at least 3 years.
4
Paragraph (1)(a) does not apply to a supplier marketing only to non-professional final consumers.
PART 5 Enforcement etc.
Inspectors
19
1
The appropriate authority must appoint inspectors for the purposes of the enforcement of these Regulations.
2
An inspector has the powers set out in Schedule 4.
3
A person must not intentionally obstruct an inspector in the exercise of any powers conferred by these Regulations.
Offences and penalties
20
1
It is an offence to fail to comply with —
a
a notice served under paragraph 2 or 3 of Schedule 4;
b
an enforcement notice served under paragraph 4(1)(a) of Schedule 4; or
c
a prohibition notice served under paragraph 4(1)(b) of Schedule 4.
2
A person guilty of an offence is liable on summary conviction to a fine not exceeding level 3 on the standard scale.
Offences by bodies corporate
21
1
If an offence under these Regulations committed by a body corporate is proved —
a
to have been committed with the consent or connivance of an officer, or
b
to be attributable to any neglect on the officer’s part,
the officer as well as the body corporate is guilty of the offence and liable to be proceeded against and punished accordingly.
2
If the affairs of a body corporate are managed by its members, paragraph (1) applies in relation to the acts and defaults of a member in connection with the member’s functions of management as if the member were a director of the body.
3
“Officer”, in relation to a body corporate, means a director, member of the committee of management, chief executive, manager, secretary or other similar officer of the body, or a person purporting to act in any such capacity.
Offences by partnerships or unincorporated associations
22
1
Proceedings for an offence under these Regulations alleged to have been committed by a partnership or an unincorporated association may be brought in the name of the partnership or association.
2
For the purposes of such proceedings, rules of court relating to the service of documents are to have effect as if the partnership or association were a body corporate.
3
For the purposes of such proceedings in England and Wales, section 33 of the Criminal Justice Act 1925 and Schedule 3 to the Magistrates’ Courts Act 1980 apply as they apply in relation to a body corporate.
4
For the purposes of such proceedings in Northern Ireland, section 18 of the Criminal Justice Act (Northern Ireland) 1945 and Schedule 4 to the Magistrates’ Courts (Northern Ireland) Order 1981 apply as they apply in relation to a body corporate.
5
A fine imposed on a partnership or association on its conviction for an offence under these Regulations is to be paid out of the funds of the partnership or association.
6
Where an offence under these Regulations committed by a partnership is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner, that partner (as well as the partnership) is guilty of the offence and is liable to be proceeded against and punished accordingly.
For these purposes, “partner” includes a person purporting to act as a partner.
7
Where an offence under these Regulations committed by an unincorporated association is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, an officer of the association, that officer (as well as the association) is guilty of the offence and is liable to be proceeded against and punished accordingly.
For these purposes, “officer” means an officer of the association or a member of its governing body, or a person purporting to act in such a capacity.
Transitional provisions
23
1
This regulation applies where plant material is taken from parent plants existing before 30th September 2012 and meeting the conditions set out in regulation 12 .
2
A supplier may market such plant material, notwithstanding the provisions of these Regulations, provided that it is accompanied by a document stating that it is marketed in accordance with Article 21 of Council Directive 2008/90/EC , or is labelled to that effect.
3
This regulation applies from 30th September 2012 and ceases to have effect on 31st December 2018.
Revocations
24
The following are revoked —
a
the Marketing of Fruit Plant Material Regulations 1995 ;
b
the Marketing of Fruit Plant Material Regulations (Northern Ireland) 1995 ;
c
the Marketing of Fruit Plant Material (Amendment) (England) Regulations 2004 ;
d
the Marketing of Fruit Plant Material (Amendment) (Wales) Regulations 2005 ;
e
the Marketing of Fruit Plant Material Amendment (Scotland) Regulations 2004 ;
f
the Marketing of Fruit Plant Material (Amendment) Regulations (Northern Ireland) 2004 .
Jim Paice
Minister of State
Department for Environment, Food and Rural Affairs
11th August 2010