Proprietary medicinal products
Over the past couple of years, the European Commission and Parliament have been working on a proposal for a Directive to amend Directive 2001/83/EC on proprietary medicinal products.
Over the past couple of years, the European Commission and Parliament have been working on a proposal for a Directive to amend Directive 2001/83/EC on proprietary medicinal products.
The common position of the Council of the EU on the proposal was adopted in September of last year and it is anticipated that the amending Directive will formally be adopted this spring.
From the manufacturing perspective, perhaps the most significant proposal is that requiring active ingredients for use in medicinal products to be manufactured in accordance with detailed guidelines on good manufacturing practice. This requirement will also apply to Ôcertain excipientsÕ to be specified by the Commission.
The Directive does not require that manufacturers or suppliers of active ingredients and the, yet to be specified, excipients have a manufacturing authorisation; rather, it puts the onus for compliance on the product licence holder. However, the amendment does reserve the right for competent authorities to inspect such manufacturers.
For actives, the relevant GMP guideline will be ICH Guideline Q7A, which was adopted as Annex 18 to the EU Guidelines on GMP in late 2000.
It is not yet certain when the new provisions will become effective in the European Union, but it can be anticipated that there will be ongoing debate as to the steps companies need to take to fulfil their duties in this respect and also the criteria the Commission will use in drawing up the list of excipients to be covered.
This column will no doubt return to the topic when the legislation comes into effect and implementation issues begin to be debated.