Bulgarian Drugs Agency continues accepting applications for marketing authorizations

As of 1 January 2007 BDA has stoped accepting applications for marketing authorizations, renewed and variations made of medicinal products until Pharmaceuticals and pharmacies serving human Medicine Act (PPSHMA) enters into force.

Bugarian office of Farmavita.Net has confirmed that  BDA continues accepting applications after new Human Medicines Law has bee adopted in Apirl 2007.

Regarding the delay of the adoption of the new Pharmaceuticals and pharmacies serving human Medicine Act (PPSHMA) and the entry into force of the European legislation of 1 January 2007 and on the grounds of art. 92, par.4, point 4 of PPSHMA

1.    Applications for marketing authorizations of medicinal products the procedure of which has not been finalized by 31 December 2006 and those medicinal products which already have a marketing authorization in an EU member-state, incl. Romania, or have a non-finalized statute in another member-state, incl. Romania will be dealt with in compliance with the directions (MA01). 

2.    Marketing authorizations of medicinal products submitted by 31 December 2006 of Bulgarian manufacturers and those by countries outside the EU, which do not have a valid MA of the same medicinal product in an EU member-state, incl. Romania will be dealt with and assessed under the terms and conditions of PPSHMA until PPSHMA enters into force.

3.    Applications for the renewal and variations of medicinal products, submitted by 31 December 2006 under the national procedure will be dealt with and assessed under the terms and conditions of PPSHMA until PPSHMA enters into force.

As of 1 January 2007 BDA has  stoped  accepting applications for marketing authorizations, renewed and variations made of medicinal products until PPSHMA enters into force.

Bugarian office of Farmavita.Net has confirmed that BDA continues accepting applications after new Human Medicines Law has bee adopted in Apirl 2007.  The new Human Medicines Law has been officially published and you can download it at http://www.bda.bg/web_bul/regulations/new/zakoni/ZLPHM.pdf  Unfortunately, we can not provide English translation.

Agency has also informed that on the grounds of art. 81 (2) and regulation (EO) No. 726/2004 of the European Parliament and the Council of Europe, as of 1 January 2007 the marketing authorizations of medicinal products, issued under the national procedure, having marketing authorizations in the European Union as well under the centralized procedure, are also terminated. Relevant to existing marketing authorizations in the European RMS, the national Bulgarian MA will be  continued as marketing authorization in Concerned Member State (CMS). 

Sources: Bulgarian Drug Agency ; Farmavita.Net - Bulgarian Office 

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