The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

Amendments to the Applications Regulations U.K.

2.—(1) The Applications Regulations are amended as follows—

(2) In regulation 2 (interpretation)—

(a) in the definition of “the 2001 directive”, at the end insert —

“as amended by—

(i) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components,

(ii) Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use,

(iii) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use; and

(iv) Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use;”;

(b) in the definition of “imported proprietary product” for “imported other than from a member State of the European Communities;” substitute “ imported from a third country; ”;

(c) for the definition of “proprietary medicinal product and ready made veterinary drug” substitute the following definition— “ “proprietary medicinal product” has the same meaning as in section 7(7) of the Act; ”;

(d) in the definition of “standard provisions for licences” after “1971”, add “ , or the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 ”;

(e) insert, in the appropriate alphabetical places, the following definitions—

““qualified person” means—

(a)

a person whose qualifications and experience satisfy the requirements of Article 49 or 50 of the 2001 Directive, or

(b)

where—

(i)

an application for a licence is made before 30th April 2013; and

(ii)

insofar as the activities of in respect of which the application is made are limited to traditional herbal medicinal products, a person who, without satisfying the requirements referred to in paragraph (a), has been engaged in activities equivalent to those to be performed in accordance with Article 51 of the 2001 Directive in respect of traditional herbal medicinal products on or before 30th April 2011;

“responsible person” means the person who will be responsible for ensuring in relation to any wholesale distribution activity carried out pursuant to a licence that—

(a)

any conditions under which the licence has been granted have been, and are being, complied with; and

(b)

the quality of relevant medicinal products which are being handled by the wholesale dealer's licence holder are being maintained in accordance with the requirements of the marketing authorizations applicable to those products;

“traditional herbal medicinal product” has the meaning given by Article 1(29) of the 2001 Directive;”.

(3) In regulation 3 (form of application for a manufacturer's licence and for a wholesale dealer's licence)—

(a) in paragraph (1), after “manufacturer's licence“ insert “ , where that licence relates to the manufacture or assembly of medicinal products, ”; and

(b) after paragraph (1), insert the following paragraph—

“(1A) Every application for the grant of a manufacturer's licence where that licence relates to import from a third country of medicinal products shall contain or be accompanied by the particulars specified in Schedule 1A to these Regulations;”.

(4) In Schedule 1 (particulars required on application for grant of a manufacturer's licence)—

(a) for paragraph 2, substitute

“2.   Whether the application relates to any medicinal products which are not medicinal products to which the 2001 Directive applies, and if so, in respect of those products, the period for which the licence is desired, where it is for less than five years.”;

(b) in paragraph (4)—

(i) omit sub-paragraphs (b) and (d), and

(ii) in sub-paragraph (c), omit “or animals”; and

(c) in paragraph 7, for sub-paragraph (5), substitute—

“(5) The name and address and degrees, diplomas or other qualifications of the qualified person.”.

(5) After Schedule 1, insert the following Schedule—

“SCHEDULE 1A U.K. PARTICULARS REQUIRED ON AN APPLICATION FOR THE GRANT OF A MANUFACTURER'S LICENCE WHERE THAT LICENCE RELATES TO THE IMPORT OF MEDICINAL PRODUCTS FROM A THIRD COUNTRY

1.   The name and address of the applicant, and where the applicant is not to be the licence holder, the name and address of the proposed licence holder.

2.   Whether the application relates to any medicinal products which are not medicinal products to which the 2001 Directive applies, and if so, in respect of those products, the period for which the licence is desired, where it is for less than five years.

3.   A statement of the importation operations to which the licence is to relate.

4.   The name, pharmaceutical form, country of origin and Marketing authorization number of each imported proprietary product.

5.   The address of each site where the importation operation is to take place.

6.   The address of each site where any testing associated with the importation is to take place.

7.   The address of each site where it is proposed to store or distribute proprietary medicinal products.

8.   A statement indicating the facilities and equipment available at each site for storing the proprietary medicinal products, and distributing them.

9.   A statement of any manufacturing operations, other than those to which the licence relates, that are carried on by the applicant at each of the sites referred to above, and of the substances or articles which are the subject of any such operation.

10.   The name and address and degrees, diplomas or other qualifications of the qualified person.

11   The name and degrees, diplomas or other qualifications and experience of the person in charge of quality control.

12.   A description of the arrangements for storage of the medicinal products after importation.

13.   A description of the arrangement at each site for ensuring a satisfactory turn-over of stock of proprietary medicinal products.

14.   A description of the arrangements for—

(a) maintaining records of importation;

(b) maintaining records of analytical and other testing procedures applied in the course of importation for ensuring compliance; and

(c) keeping reference samples of the medicinal products.”.

(6) In Schedule 2 (particulars required on an application for the grant of a wholesale dealer's licences)—

(a) for paragraph 2, substitute—

“2.   Whether the application relates to any medicinal products which are not a medicinal products to which the 2001 Directive applies, and if so, in respect of those products, the period for which the licence is desired, where it is for less than five years.”;

(b) in paragraph 3, omit sub-paragraph (e);

(c) in paragraph 4—

(i) omit sub-paragraphs (b) and (d), and

(ii) in sub-paragraph (c), omit “or animals”;

(d) in paragraph 6, omit “Where the licence relates to imported proprietary products or imported ready made veterinary drugs, the statement shall indicate the description of the medicinal products”;

(e) for paragraph 8A, substitute

“8A.   The name and address and the degrees, diplomas and qualifications of the responsible person”; and

(f) in paragraph 8B for “paragraph 4A of Schedule 3 to the Standard Provisions Regulations”, substitute “ regulation 8(4) of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 ”.