29. Is there a notification form on your website for launch or resumption of MP supplies to the market after submission of application for granting of exemption pursuant to Section 34a (4) of the Act on Pharmaceuticals? To whom and how should this notifi
The Act on Pharmaceuticals does not set out any special form of this notification. Notifications submitted pursuant to Section 34 a (4) of the Act on Pharmaceuticals shall contain the name of medicinal product, its code, batch, distributor, date of launch or resumption of market supplies of MP, and the number of packs. This notification shall be sent to SUKL by mail or electronically to contact persons listed on the website http://www.sukl.cz/leciva/kontakty . The notification shall be submitted pursuant to the Act No. 500/2004 Coll., Administrative Code. In parallel, the launch or resumption of MP supplies must be notified in a standard manner pursuant to Section 33 (2) of the Act on Pharmaceuticals (see Question 4).