02.02.2011
To the attention of interested persons
Based on Scientific Council Decision (SCD) of the National Agency for Medicines and Medical Devices No. 7 of 23 March 2010 on approval of switch of classification for supply of certain metamizole-containing medicinal products, from over the counter release to release on medical prescription (retained by pharmacies), all such medicinal products are to be released in accordance with NMA SCD, starting with 1 April 2011.
It should be emphasised that this measure only refers to release on medical prescription retained in the pharmacy, for all metamizole-containing medicinal products, and not to change of the legal deadline for implementation of the respective authorisation (MA), as stipulated in Order of the Minister of Health No. 279/2005. This measure also applies to all batches manufactured prior to this Decision, which can continue on the market in packages compliant with procedures issued before the change of the respective MA.
Please find attached the list of all metamizole-containing medicinal products to be released on medical prescription only as of 1 April 2011.
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