3 Amendments of Vittorio PRODI related to 2008/0261(COD)
Amendment 105 #
Proposal for a directive – amending act
Recital 13 a (new)
Recital 13 a (new)
(13a) Where good manufacturing practices for excipients or equivalent systems are already in place and well- regulated, they should be taken into account in this Directive.
Amendment 175 #
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 46 – point f – subparagraph 1
Article 46 – point f – subparagraph 1
(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a Member State. Excipients which comply with equivalent good manufacturing practice and good distribution practice, such as IPEC-PQG, EFfCI, HACCP and/or ISO9001/ISO22000, are exempted from further requirements.
Amendment 214 #
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o a (new)
Article 54 - point o a (new)
(oa) details of the product source (country, firm, production site) with a view to ensuring the traceability of the active pharmaceutical ingredient and where the active ingredient is produced outside the European Union, an indication of the country of origin on the medicinal product package.