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Qualified Pharmacist In Wholesale Distribution
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Published on 1st May 2000
To date there are still ongoing discussions between the Chamber of Pharmacists, Chamber of Commerce and Government so as to clarify the role of the Qualified Person (Q.P.) for wholesale dealers. This requirement became effective as from 1st August 1999. All wholesale dealers should have by now appointed a pharmacist to take up the responsibilities as outlined in DH circular 174/99.
In July two (2) Extraordinary General Meetings (E.G.M.) were held by the Chamber of Pharmacists so as to discuss the above-mentioned DH circular 174/99. During the first E.G.M. it was agreed that the Chamber of Pharmacists set up a working committee so as to draw up a report in accordance to EU standards vis a vis the responsibilities that were outlined in DH circular 174/99. Furthermore, the sub-committee was also asked to make its recommendations to the Chamber as to what line of action should be taken. The working subcommittee consisted of 5 pharmacists who worked in different areas of practice in both the public as well as the private sector.
This report/document, which described various aspects of Good Distribution Practice (GDP) and distinguished between Responsible Person (R.P.) and Qualified Person (Q.P.) was presented by the working sub-committee during the second E.G.M. References to GDP included (1) EU GDP Guide introduced in 1994 (2) Rules and Guidelines for Pharmaceutical manufacturers and distributors (the 'Orange Guide') London Stationary Office.
Members present at the E.G.M. posed various questions and all of these are at present being discussed. For example, (a) the strength of the regulatory board, (b) "sales to unauthorised persons", (c) inspection procedures and respective consequences in case of irregularities.
In the meantime the Chamber of Pharmacists is keeping a register for those pharmacists who are Q.P.s for any licenced wholesale dealer. If you have not yet informed the Chamber that you are a registered Q.P. feel free to contact us. Subsequently you will be kept informed as to any discussions currently being held with the Government so as to further define this role.
May we bring to your attention that this is a role that should be carried out professionally and that you are legally bound to perform this role as specified in DH circular 174/99. However, due to the fact that some of the requirements laid down by government in DH circular 174/99 are still being discussed and clarified the Chamber of Pharmacists is proposing that all the requirements are implemented gradually within specified time frames.
The last document that was presented by the subcommittee in February 2000 includes a set of draft guidelines for Q.P. (see below) These were presented separately during an E.G.M. as well as to the Government. The main points that are still being tackled and upon which major emphasis is placed are Guidelines 1A and 1B. We will keep you informed as to all latest news and updates on this matter.
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