04.01.2017
To the attention of all wholesale distributors of medicinal products
You are reminded that, in accordance with provisions of Article 31 (1) of Order of the Minister of Health no. 131/2016 on approval of Rules on authorisation of human medicinal product wholesalers, Good Distribution Practice certification and registration of brokers of medicinal products for human use, units authorised for wholesale distribution on entry into force of the Rules should obtain a Good Distribution Practice certificate in maximum 2 years.
Considering that this deadline expires on 11 February 2018, please be aware that you should submit in due time the applications for inspection planning, in order to allow finalisation of the procedure until the specified date.
Otherwise, the wholesale distribution unit shall discontinue its activity on 11 February 2018, until finalisation of the procedure with release of a Good Practice certificate for wholesale distribution.