S.L. 437.108 · Good Manufacturing Practice For (S.L. 437.108)
S.L. 437.108 ст. 2Interpretation. Cap. 437.
(1) For the purposes of these regulations and unless the context otherwise requires, the following definitions shall apply:
"the Act" means the Veterinary Services Act;
"the Commission" means the European Commission;
"competent authority" means the Department of Veterinary Services, or any other authority or authorities authorised by the Department of Veterinary Services to act on its behalf;
"good manufacturing practice" shall mean the part of quality assurance with ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use;
"manufacturer" shall mean any holder of the authorization referred to in Article 44 of Directive 2001/82/EC;
"pharmaceutical quality assurance" means the sum total of the organized arrangements made with the object of ensuring that veterinary medicinal products are of the quality required for their intended use;
"qualified person" shall mean the person referred to in Article 52 of Directive 2001/82/EC;
"veterinary medicinal products" means veterinary medicinal products as set out in Article 1(2) of Council Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products.
(2) Unless the context otherwise requires, words and phrases used in these rules which are not defined herein shall have the same meaning assigned to them in article 2 of the Act.
Ссылается на
- S.L. 437.108 ст. 1
- S.L. 437.108 ст. 44
- S.L. 437.108 ст. 52