Revision is part of the process needed to enact the Falsified Medicines Directive, says Mike Murray, head of Manufacturing & Environment, ABPI
Mike Murray, Head of Manufacturing & Environment at the ABPI
The European Commission recently issued for consultation a draft revision of its Guideline on Good Distribution Practice (GDP). The Guidelines were first published in 1994 and the new revision is necessary to take into account the provisions of Directive 2011/62/EU amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (the ‘Falsified Medicines Directive’).
Article 80g of Directive 2001/83/ EC as amended by the Falsified Medicines Directive requires that distributors comply with the principles and guidelines of GDP. Manufacturers distributing their own products should also comply with GDP. According to article 85b, persons brokering medicinal products shall be subject to certain provisions applicable to wholesaler distributors, as well as specific provisions for brokering.
The revised draft guideline hence addresses in detail the role and responsibilities of wholesale distributors as well as of brokers. The relevant sections of these guidelines should also be considered for implementation by, among others, governments, regulatory bodies, international procurement organisations and donor agencies.
The draft revised Guideline is available at http://ec.europa.eu/health/files/eudralex/vol-4/2011-07_gdpguidline_publicconsultation.pdf and comments on it are due by 31 December.
The draft revision is one of a number of regulatory instruments and guidelines that will require drafting or amendment to enact the Falsified Medicines Directive and the progress of these will be followed in this column.