title: Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.
abstract: European legislation for medicines places the emphasis on an assessment of quality, safety and efficacy during the procedure for the granting of marketing authorisations for medicines, in order to protect patient health. The integrated European regulatory system involves the participation of a network of experts from the agencies of the member states that takes part in the European procedures for the authorisation of medicines. On the way to full membership in the EU, candidate countries and potential candidates have to transpose and implement the European directives for medicinal products; they must also strengthen their scientific and administrative capacities. Croatia acquired good experience in implementing the simplified marketing authorisation procedure for medicines authorised in the EU pursuant to the New Collaboration Agreement between Drug Regulatory Authorities in Central and East European Countries (nCADREAC), which helps it to exchange information and prepare for the implementation of European procedures. However, there are still some provisions to transpose before actual full membership, and also dossier upgrading, in which the marketing authorisation holder has to harmonise its documentation about a medicinal product with the requirements of the directives, if a product already on the market was not previously approved in line with current European legislation. Collaboration with the European Medicines Agency (EMA) through an Instrument for Pre-Accession (IPA) provides candidate countries and potential candidates the opportunity for education and training in some regulatory activities as well as the participation of their representatives as observers in some EMA committees and working groups. Some characteristics of the national regulatory frameworks of the countries of South East Europe in their efforts to achieve harmonisation with EU legislation are presented in this paper.
authors.affiliation: Agency for Medicinal Products and Medical Devices, Zagreb, Croatia. sinisa.tomic@almp.hr
authors.forename: Sinisa
authors.initials: S
authors.lastname: Tomić
authors.forename: Anita Filipović
authors.initials: AF
authors.lastname: Sucić
authors.forename: Adrijana Ilić
authors.initials: AI
authors.lastname: Martinac
mesh_terms: D003257:Consumer Product Safety; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions; D005061:Europe, Eastern; D005062:European Union; D033161:Government Regulation; D007373:Interinstitutional Relations; D007880:Legislation, Drug; D040541:Marketing / Q000331:legislation & jurisprudence*; D004364:Pharmaceutical Preparations / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations