SERVICES

REGULATORY AFFAIRS

 

MAH

AB OVO can represent you in front of the Authorities and become Marketing Authorisation Holder of your products until you start with distribution on your behalf. This would allow you to reduce your costs related to: firm opening, staff employment, rental costs, lawyer and bookkeeping services.

ACCORDING TO THE LAW ON MEDICINES AND MEDICAL DEVICES:

Article 27

Following entities shall file the application for a marketing authorisation to the Agency:

1) a medicinal product manufacturer who is licensed to manufacture medicinal products in the Republic of Serbia;
2) agent or representatives of foreign manufacturers based in the Republic of Serbia;
3) representative of a foreign legal entity that is not the medicinal product manufacturer, but the marketing authorisation holder in the European Union member states or in countries that have the same requirements for the issuance of a marketing authorisation for a medicinal product based in the Republic of Serbia;
4) legal entity based in the Republic of Serbia onto which the manufacturer, referred to in Item 1) of this Paragraph, transferred the marketing authorisation, or to whom it gave the right to acquire the properties of a marketing authorisation holder for medicinal products from its production line; Applicant for a marketing authorisation under Paragraph 1 of this Article (hereinafter referred to as: the applicant) must have a person responsible for pharmacovigilance, as well as a person responsible for documentation in the process of obtaining the marketing authorisation, its variations and renewals, with whom it concluded a full-time employment contract for the indefinite period of time.

Persons referred to in Paragraph 2 of this Article must be graduates from the Faculty of Medicine, Dentistry or Pharmacy, or the Faculty of Veterinary Medicine for veterinary medicinal products. In addition to the conditions specified in Paragraph 2 of this Article, the applicants referred to in Paragraph 1, Items 3) and 4) of this Article shall have the person responsible for batch release that meets the requirements of this Law and regulations adopted to implement this Law.

Applicant shall be responsible for documentation in the procedure of obtaining a marketing authorisation.

MEDICINES

MARKETING AUTHORISATION PROCEDURE

»  Regulation of the applicant’s legal status
»  Preparation & Submission of dossiers to the ALIMS*
» Follow-up procedures & Communication with the ALIMS representatives
» Text & Document translation
» Text formatting
» Creating packaging mock-ups
» Readability testing & Score

LIVECYCLE MANAGEMENT

» MA extensions
» MA Variations & Renewals
» Reviewing of the promotional materials
» Labelling & Packaging

PHARMACOECONOMICS

» Medicinal product pricing & Reimbursement
*Medicines and Medical Devices Agency of Serbia

MEDICAL DEVICES

» Registration of business entities at the ALIMS*
» Application forms
» Text translations & Revision
» Professional reviewing of promotional materials
» Preparation of promotional materials
» MD labelling
» MD vigilance *Medicines and Medical Devices Agency of Serbia

FOOD SUPPLEMENTS

» Food business operators (FBO) & Status regulation
» Preparation & Submission of dossiers to the Authorities
  -Pharmaceutical Faculty in Belgrade, in charge of product categorization
  -Referent laboratory in charge of products’ content analysis (“Dr Milan Jovanovic Batut” Institute of Public Health of Serbia)
  -Ministry of Health, responsible for entering products into the Database
» Text translations & Revision
» Professional reviewing of promotional materials
» Preparation of promotional materials