The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 and shall come into force on 19th August 2010.

(2) In these Regulations—

“the Act” means the Medicines Act 1968(1);

“advanced therapy medicinal product” has the meaning that expression bears in paragraph 1(a) of Article 2 of Regulation (EC) No. 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products(2);

“the Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(3);

“exempt advanced therapy medicinal product” means an advanced therapy medicinal product of the kind described in Article 3.7 of the Directive;

“the guidelines on good distribution practice” means the Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) published by the European Commission pursuant to Article 84 of the Directive; and

“the principles and guidelines of good manufacturing practice” means the principles and guidelines of good manufacturing practice set out in Commission Directive 2003/94/EC(4) and the guidelines drawn up pursuant to Article 5 of Regulation (EC) 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products.

Disapplication of section 7 of the Medicines Act 1968 to exempt advanced therapy medicinal products

2.  Section 7 of the Act(5) (dealing with medicinal products and product licences) shall not apply in relation to an exempt advanced therapy medicinal product.

Licence conditions for exempt advanced therapy medicinal products

3.—(1) The requirements in Schedule 1 have effect as provisions of any manufacturer’s licence insofar as such a licence relates to an exempt advanced therapy medicinal product.

(2) The standard provisions, for the purposes of Part II of the Act, for manufacturer’s licences insofar as those licences relate to exempt advanced therapy medicinal products are set out in Schedule 2.

(3) The requirements in Schedule 3 have effect as provisions of any wholesale dealer’s licence insofar as such a licence relates to an exempt advanced therapy medicinal product.

(4) The standard provisions, for the purposes of Part II of the Act, for wholesale dealer’s licences insofar as those licences relate to exempt advanced therapy medicinal products are set out in Schedule 4.

Traceability

4.—(1) A person who treats a patient with an advanced therapy medicinal product commits an offence if there is no system in place for patient and product traceability in relation to such treatment containing sufficient detail to enable the linking of the product to the patient who received it and vice versa.

(2) A person who treats a patient with an advanced therapy medicinal product commits an offence if the treatment involves a product which contains human cells or tissues, the traceability system referred to in paragraph (1) is not complementary to, and compatible with, the requirements laid down in—

(a)Articles 8 and 14 of Directive 2004/23/EC(6) as regards human cells and tissues other than blood cells, and

(b)Articles 14 and 24 of Directive 2002/98/EC(7) as regards blood cells.

(3) It is a defence to an offence under paragraph (1) or, as the case may be, paragraph (2) if the person who treats a patient was assured in writing before the treatment was given that a system of traceability as described in paragraph (1) or, as the case may be, paragraph (2) was in place in relation to the treatment given by that person.

(4) It is an offence for a person to give an assurance in writing to a person (“P”) who treats a patient with an advanced therapy medicinal product that a system of traceability as described in paragraph (1) or paragraph (2) is in place in relation to treatment with an advanced therapy medicinal product given by P if no such system is in place.

(5) Any person guilty of an offence under paragraph (1), (2) or (4) shall be liable—

(a)on summary conviction, to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

Traceability in the event of bankruptcy or liquidation of holder of manufacturer’s licence for exempt ATMP

5.  Paragraphs 13C(8), 14 and 17(9) of Schedule 3 (offences, penalties etc.) to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(10) apply to the holder of a manufacturer’s licence in respect of an exempt advanced therapy medicinal product as though in paragraph 13C—

(a)the reference to the holder of a marketing authorisation were a reference to the holder of a manufacturer’s licence relating to an exempt advanced therapy medicinal product; and

(b)the reference to the European Medicines Agency established by Regulation (EC) No. 726/2004(11) were a reference to the licensing authority.

Amendment of the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971

6.  In the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971—

(a)after regulation 1A(12) (veterinary medicinal products), insert—

“Advanced therapy medicinal products which are not relevant medicinal products

1B.—(1) These Regulations do not apply in relation to exempt advanced therapy medicinal products.

(2) In this regulation—

(a)“advanced therapy medicinal product” has the meaning that expression bears in paragraph 1(a) of Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products; and

(b)“an exempt advanced therapy medicinal product” means a product of the kind described in Article 3.7 of the 2001 Directive.”; and

(b)in regulation 2(13) (interpretation) for the definition of “the 2001 Directive” substitute—

““the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicines for human use, as amended by—

Amendment of the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971

7.—(1) The Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971(14) are amended in accordance with the following paragraphs.

(2) In regulation 2(1) (interpretation)—

(a)after the definition of “the Act”, insert—

““advanced therapy medicinal product” has the meaning that expression bears in paragraph 1(a) of Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products;”;

(b)for the definition of “the 2001 Directive” substitute—

““the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicines for human use, as amended by—

(c)after the definition of “the 2001 Directive”, insert the following definition—

““exempt advanced therapy medicinal product” means a product of the kind described in Article 3.7 of the 2001 Directive;”.

(3) In Schedule 1 (particulars required on an application for the grant of a manufacturer’s licence), add after paragraph 10—

“11.  Where the application relates to an exempt advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow product traceability containing sufficient detail to enable the linking of a product to the patient who received it and vice versa.”.

Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

8.  The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(15) are amended in accordance with Schedule 5.

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

9.—(1) The Medicines for Human Use (Clinical Trials) Regulations 2004(16) are amended in accordance with the following paragraphs.

(2) In regulation 15(10) (ethics committee opinion)—

(a)in the definition of “the specified period”, in sub-paragraph (a), after “genetically modified organism” insert “or a tissue engineered product”; and

(b)for the definition of “specialist group or committee” substitute—

““specialist group or committee” means a group or committee whose functions include the provision of advice on ethical or scientific issues in relation to—

(3) In regulation 19 (authorisation procedure for clinical trials involving medicinal products for gene therapy etc.), for paragraph (1) substitute—

“(1) This regulation applies to clinical trials involving—

(a)medicinal products for gene therapy and somatic cell therapy, including xenogenic cell therapy;

(b)medicinal products containing genetically modified organisms; or

(c)tissue engineered products.”.

(4) In paragraph 8(4) of Schedule 2 (co-opting members to the Gene Therapy Advisory Committee), for “Paragraph (3)” substitute “Sub-paragraph (3)”.

Amendment of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

10.  In the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005(17)—

(a)in regulation 1(2) (citation, commencement and interpretation), for the definition of “relevant medicinal product” substitute—

““relevant medicinal product” means a medicinal product for human use to which the provisions of the Directive apply other than an advanced therapy medicinal product within the meaning that expression bears in paragraph 1(a) of Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products;”; and

(b)in—

(i)paragraph 7(8) of Schedule 2 (standard provisions which may be incorporated in a manufacturer’s licence relating to the import of relevant medicinal products from a third country); and

(ii)paragraph 3(8) of Schedule 4 (standard provisions which may be incorporated in a wholesale dealer’s licence),

delete “, price list”.