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

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(1) (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(2) (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—

(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,

(b)

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

(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,

(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,

(e)

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006,

(f)

Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007,

(g)

Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008,

(h)

Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009, and

(i)

Commission Directive 2009/120/EC of 14 September 2009;”.

(1)

S.I. 1971/972. Regulation 1A was inserted by S.I. 2005/2745 and revoked by S.I. 2005/2789 in relation to manufacturers’ licences and wholesale dealers’ licences insofar as such licences relate to relevant medicinal products as defined in S.I. 2005/2789.

(2)

Relevant amending instruments are S.I. 2002/236, 2003/2321 and 2005/2789.