MARKETING AUTHORIZ.
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MARKETING AUTHORIZATION  

As a part of regulatory affair services we prepare documentation and obtain marketing authorization for medicines and medical devices in Serbia, Montenegro, and Republika Srpska such as:

  • Preparation of registration dossiers according to EU guidelines
  • Updating/reformatting of the registration documentation
  • National applications with follow up until Marketing Authorization
  • Planning and monitoring of all stages of clinical trials based on GCP
  • Preparation of expert preclinical report
  • Elaboration of expert clinical report
  • Elaboration of pharmaceutical/chemical/biological documentation
  • Elaboration of pharmaceutical and toxicological documentation
  • Preparation of Periodic Safety Update Reports (PSURs)
  • Preparation of Summaries of Product Characteristics (SPCs)
  • Organization and implementation of pharmacovigilance. Identification, monitoring and response to new findings in respect of drug administration risks or drug interaction with other products or substances
  • Design of inside and outside drug packaging
 
 
  Direktiva evropske Unije
2001/83/EC
 
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  Direktiva evropske Unije
2001/20/EC
 
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  Direktiva evropske Unije
2001/24/EC
 
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  Directive
93/42/EEC
 
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  Pharmamedia, Majke Jevrosime 14a, 11000 Belgrade, Serbia,
tel: +381 11 380 74 33, 063/ 322 040, e-mail: pharmamedia@eunet.rs
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