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

Citation, commencement and interpretation U.K.

1.—(1) These Regulations may be cited as the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 and shall come into force on 30th October 2005.

(2) In these Regulations—

“the Act” means the Medicines Act 1968 M1 ;

“the 1994 Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 M2 ;

“the Applications Regulations” means the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 1971 M3 ;

“the Standard Provisions Regulations” means the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 M4 ;

“BCG” means the bacillus of Calmette and Guerin;

“BCG vaccine” means a vaccine that is a preparation of the bacteria in a living pure culture of a strain of the bacillus of Calmette and Guerin;

“biological medicinal product” means a medicinal product, the active substance of which is a biological substance;

“biological substance” means a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control;

“blood” means whole human blood;

“blood component” means a therapeutic constituent of blood (red cells, white cells, platelets and plasma);

“blood product” means any industrially prepared medicinal product for human use derived from human blood or human plasma and includes but is not limited to albumin, coagulation factors and immunoglobulins of human origin, but does not include blood or blood components;

“Commission Directive 2003/94/EC” means Commission Directive 2003/94/EC M5 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and for investigational medicinal products for human use;

“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 M6 , as amended by—

(a)

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 M7 ,

(b)

Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use M8 ,

(c)

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 M9 and

(d)

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 M10 ;

“EEA State” means a member State, Norway, Iceland or Liechtenstein;

“exempt relevant medicinal product” means a relevant medicinal product to which paragraph 1 of Schedule 1 to the 1994 Regulations or any equivalent legislation in any EEA State other than the United Kingdom applies;

“the guidelines on good distribution practice” means the Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C63/03) published by the European Commission pursuant to Article 84 of the Directive M11 ;

“intermediate product” means a substance, other than a starting material, which—

(e)

has been manufactured for use in the manufacture of medicinal products, and

(f)

is intended for further processing by a manufacturer of such products;

“marketing authorization” means—

(a)

a marketing authorization granted by the licensing authority under the 1994 Regulations;

(b)

a marketing authorization issued by the competent authority of an EEA state, other than the United Kingdom, in accordance with the Directive;

(c)

a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 M12 or Regulation (EC) No. 726/2004 M13 ;

(d)

a traditional herbal registration granted by the licensing authority under the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 M14 ; or

(e)

a certificate of registration granted by the licensing authority under the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994 M15 ;

“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 M16 ;

“qualified person” means—

(a)

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

(b)

insofar as the activities of the qualified person are limited to traditional herbal medicinal products, a person who, without satisfying the requirements referred to in paragraph (a)—

(i)

has been engaged in activities equivalent to those to be performed in accordance with Article 51 of the Directive in respect of traditional herbal medicinal products on or before 30th April 2011; and

(ii)

has, whilst they continue to be engaged in activities equivalent to those to be performed in accordance with Article 51 of the Directive, been named as a qualified person in an application for a manufacturer's licence which is made in accordance with the requirements of the Applications Regulations and before 30th April 2013;

“relevant medicinal product” means a medicinal product for human use to which the provisions of the Directive apply;

“serum” means a fluid fraction of coagulated blood;

“smallpox vaccine” means a vaccine that is a preparation of an infective vaccinia virus;

“toxins” means substances used in the diagnosis, prevention or treatment of disease consisting wholly or partly of poisonous substances derived from specific micro-organisms, plants or animals;

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

“vaccines” means antigenic substances which consist wholly or partly of—

(a)

any micro-organisms, viruses or other organisms in any state,

(b)

any toxins of microbial origin which have been detoxified (toxoids), or

(c)

any extracts or derivatives of any micro-organisms or of any viruses,

being substances which, when administered to human beings are used for the treatment of specific diseases.

(3) Expressions used in these Regulations which are used in any provision of the Act have the meaning which they bear in the Act.

Marginal Citations

M1 1968 c. 67.

M2 S.I. 1994/ 3144 as amended by S.I. 1998/3105, 200/292, 2001/795, 2002/236, 2002/542, 2003/2321, 2004/3224 and 2005/768.

M3 S.I. 1971/974 as amended by S.I.1977/1052, 1978/1140, 1983/1725, 1993/832 and 2002/236.

M4 S.I. 1971/972, as amended by S.I. 1974/1523, 1977/675, 1983/1730, 1992/2846, 1999/4, 2002/236, 2003/2321, 2004/1031 and 2005/1710.

M5 OJ No. L262, 14.10.2003, p.22.

M6 OJ No. L311, 28.11.2001, p67

M7 OJ No. L33, 8.2.2003, p30.

M8 OJ No L159, 27.6.2003, p 46.

M9 OJ No L 136, 30.4. 2004, p.85.

M10 OJ No. L136, 30.4.2004, p.85.

M11 OJ No. C63 1.3.1994.

M12 OJ No. L214, 24.8.1993, p.1.

M13 OJ No L136, 30.4.2004, p.1.

M14 S.I. 2005/2750.

M15 S.I. 1994/105; as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 542, 2003/625 and 2321, and 2004/666.

M16 OJ No. L 262 14.10.2003, p 22.