The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003

Regulation 2(2)(a)

SCHEDULE 1 Amendments to regulation 2(1) of the principal Regulations

	Text	Amendment
1.	In the definition of “assistance in connection with a mutual recognition application”	(a) for “the second paragraph of Article 17.3 of the Directive 81/851/EEC” substitute: “the second paragraph of Article 32.1 of Directive 2001/82/EC” (b) for “specified in Articles 18.2 and 18.3” substitute: “specified in Article 33”
2.	After “Directive 92/74”	Add the following new definition: ““Directive 2001/82/EC” means Directive 2001/82/EC of 6th November 2001 on the Community code relating to veterinary medicinal products;”
3.	To the definition of “EEA Agreement”	for “as amended by the Decision of the EEA Joint Committee No 7/94;” substitute: “amended as at the date of making of the Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003;”
4.	After the definition of “EEA State”	Add the following new definition: ““export certificate” means a certificate issued under section 50 of the Act;”
5.	After the definition of “the Ministers”	Add the following new definition: ““mutually recognised marketing authorisation” means a marketing authorisation which has a mutual recognition from a member State;”
6.	After the definition of “Regulation (EC) No 541/95”	Add the following new definition: ““Regulation (EC) No 1084/2003” means Commission Regulation (EC) No 1084/2003 of 3rd June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State;”
7.	After the definition of “relevant authority”	add the following new definitions: ““specific batch control” means consideration by the licensing authority of a marketing authorisation or animal test certificate holder’s documentation relating to a specific batch of a veterinary medicinal product (other than an immunological product) where the quality characteristics of that batch, or of a starting material used during its manufacture, differ from those detailed in the marketing authorisation or animal test certificate, so that the licensing authority may, prior to the release of the batch in question onto the market, form a view as to whether action under the 1994 Regulations would be required either to instigate a recall or to prohibit the supply of the veterinary medicinal product should the batch be placed on the market; “starting material” means in relation to specific batch control a material required to produce the finished veterinary medicinal product for sale, and includes the finished product’s container and packaging;”
8.	In the definition of “variation with extras”	after “falling within Annex II to Regulation (EC) No 541/95” add: “except in the case of a mutually recognised marketing authorisation, where it means changes falling within Annex II to Regulation (EC) No 1084/2003”
9.	In the definition of “Veterinary Medicinal Product”	for “Directive 81/851/EEC” substitute “Directive 2001/82/EC”