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EMEA and EU Commission – Topical News

Commission Note regarding the Switch of Classification of Medicinal Products

Dr. Brigitte Friese

Rechtsanwältin, Wyk-Wrixum auf Föhr, Germany

Arts. 71 ff. of the Human Code govern the classification of the prescription status of medicinal products. The Guideline on changing the classification for the supply of a medicinal product for human use allows the “switch” of prescription status, provided the respective criteria are complied with. In October 2008 the first EMEA opinion had been issued on the switch of prescription status of a Community marketing authorisation. In the course of this assessment certain legal issues had arisen which the Commission addresses in its Note regarding the Switch of Classification of Medicinal Products. In its note the Commission presents the following interpretation:
• A different prescription status may apply to different strengths of a medicinal product provided the risk assessment of the Article 71 criteria leads to different results in this respect.
• A different prescription status may apply to different indications of a medicinal product provided the risk assessment of the Article 71 criteria leads to different results for the different therapeutic indications.
• Community and national marketing authorisations may co-exist and be subject to different prescription status provided they refer to different therapeutic indications and the risk assessment of the Article 71 criteria leads to different results in this respect.
• In case of conflict between national and Community marketing authorisation regarding the prescription status a Community referral according to Art. 31 of the Human Code could be triggered.