Although the main legislative act governing the pharma sector in Bulgaria (the Drug Law) is often subject to amendments, on 21-Dec-2012 some major changes were promulgated. The provisions of Directive 2010/84/EU and Directive 2011/62/EU were implemented, as well as some nationally specific changes were introduced. Here are some of the main highlights:
– Detailed provisions regarding the manufacturing, import and wholesale distribution of active substances (implementing Directive 2011/62/EU);
– New figure: “broker of medicinal products” (implementing Directive 2011/62/EU);
– New registers at the Bulgarian Drug Agency for (i) the manufacturers/importers/wholesalers of APIs and for (ii) brokers of medicinal products (implementing Directive 2011/62/EU);
– Provisions regarding MA under conditions (see Directive 2001/83/EC, 21a-22c);
– Provisions regarding non-interventional post-authorisation safety studies (Directive 2010/84/EU);
– Safety features on the packing (see Directive 2001/83/EC, point “o”, implementing Directive 2011/62/EU);
– New pharmacovigilance rules (Directive 2010/84/EU, Commission Implementing Regulation (EU) No 520/2012, Regulation (EC) No 726/2004 of the European Parliament And Of The Council, as amended by Regulation (EU) No 1235/2010 of the European Parliament);
– Requirement for the formal appointment of local pharmacovigilance contact person for Bulgaria (nationally specific, based on article 104, paragraph 4 of Directive 2001/83/EC as amended by Directive 2010/84/EU);
– New set of obligations for the wholesalers and brokers to verify that the medicinal products received are not falsified (implementing Directive 2011/62/EU);
– New provisions for sale at a distance to the public and the common logo (implementing Directive 2011/62/EU);
– Tacit consent introduced to the drug store registration procedure (nationally specific);
– New pricing and reimbursement authority: National Council on pricing and reimbursement of medicinal products (nationally specific);
– Changes to the pricing and reimbursement system (nationally specific).
We will have some separate posts on different aspects of the new regulatory framework.