THE ANTI-FALSIFICATION LEGISLATION: POTENTIAL CONSEQUENCES FOR QPs
The 6th QP Forum of the European Qualified Person Association (EQPA) was held in Budapest, Hungary on 1-2 December 2011 with two parallel pre-conference sessions on 30 November.
One focus was set on the new EU anti-falsification legislation and its potential consequences for Qualified Persons. David Cockburn, Head of Manufacturing and Quality Compliance, European Medicines Agency (EMA) in London, U.K. gave a first presentation on this topic. He emphasised the need for the directive to "secure integrity and authenticity of products".
The new safety features like serial numbers and/or tamperevident seals will mainly have an impact on the QPs at parallel distributors. They need to make sure that the authenticity and the integrity is confirmed prior to the removal of original safety features. And, of course, this removal has to be done under GMP conditions.
The rules for the importation of APIs are more stringent. For instance, the QP needs to be satisfied that the supplier qualification procedures ensure verification that suppliers are registered and that they have been audited. This has to be documented in the QP Declaration. After qualifying the supplier it needs to be warranted that the raw materials are actually received from the qualified sources.
When it comes to excipients, the QP should at least check that a formal risk assessment has been performed and documented and that the suppliers are qualified accordingly. This should also take into account information in the EU database for excipient suppliers. However an audit is not mandatory but should be preformed for any excipient identified as critical.
Regarding the delegated acts, industry and the QPs need to wait for further details. The QP will need to be satisfied, though, that procedures are in place to comply with the defined conditions, e.g. for the import of APIs.
Julie Maréchal-Jamil, Senior Manager Quality & Regulatory Affairs at the European Generic Medicines Association (EGA), presented the industry's perspective. In her opinion one of the open issues is the time the overall implementation really will take. Besides the Delegated Acts, other steps need to be taken. It will be interesting to see, how the EC List of Equivalent Countries1 will be implemented. In the implementation phase of the new Directive, existing guidelines need to be revised. In addition, new guidelines will have to be developed like, for example, to define risk-assessment principles for excipients or to describe the various confirmations. Julie stressed that currently, there is "no legally defined timeframe for the development and publication of delegated and implementing acts" only a legal timeframe for the entry into force of these legislative acts once they are adopted by the EC.
EGA's main concerns with the implementation of the Directive on Falsified Medicines are:
- 1. The so-called "Written Confirmation" of compliance with EU GMP for APIs from non-EU origin - for this process no guidelines are foreseen. Amongst others, EGA sees a necessity in having a transition period and a possible risk of heterogeneous supervision of pharmaceutical import and waiver granting in different Member States in the absence of a coordination effort. Here a common central approach will be needed.
- 2. Process for the establishment of the list of EU GMP "Equivalent Countries" - here, EGA recommends to leverage existing and operating initiatives like e.g. PIC/S, or MRA and ACAA agreements but also on other similar successful initiatives (Food and Feed) where a staged approach to implementation led to a smooth transition towards a level playing field.
- 3. With regard to the registration of API-related activities for EU-based API manufacturers, importers and distributors (article 52a) duplication should be avoided for companies with EU multi-sites.
- 4. Regarding GMP/GDP for Pharmaceutical Excipients, Guidelines should provide a fair reflection of today's best practices, focusing on cost-effectiveness and existing standards like ISO. Unnecessary over-regulation should be avoided.
- 5. Authority/inspectorate funding of the implementation Details on EGA's point of view will be published in a White Paper
Both the Forum and the pre-conference workshops were rated very positive by the almost 220 delegates. The delegates rated the Forum with 1.56 (where 1 was the best rating and 6 the worst). They also very much appreciated the social event - combining an interesting sightseeing tour through Budapest, the famous capital of Hungary, and a dinner in a traditional restaurant on top of Gellért Hills.
Author:
Wolfgang Schmitt
CONCEPT HEIDELBERG
Source:
This list comprises countries the EU Commission will evaluate positively with regard to their level of adherence to GMP regulations. This will imply an evaluation by the Commission which will only be conducted upon request of the third country.
