Key amendments to the Bulgarian Drug Law

Key amendments to the Bulgarian Drug Law

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.