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

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(1)—

(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”.

(1)

S.I. 2005/2789.