Professional Documents
Culture Documents
The Person in
Region KBC Contact Number E-mail
charge of KBC
지역 무역관 무역관 담당자명 담당자 전화번호 담당자 이메일
연사 정보
Full Name Predrag Ristić
Current
Organization Pharmillennium Consulting d.o.o.
(Brief Description)
Photo
Summary:
West Balkan Countries (WBC) is commonly defined region located in the South-East Europe
including 6 independent states – Albania, Bosnia and Herzegovina, Kosovo, Former Yugoslav
Republic Macedonia, Montenegro and Serbia. None of these countries is EU member state, but all
are looking toward EU accession. Total WBC population is approximately 25 Million, while the
largest marker is Serbia having around 7,5M population.
All the above WB countries, along with Moldova are signatories of the Central European Free Trade
Agreement (CEFTA) which facilitates trade relationships as free-trade zone between those countries.
Further, especially Serbia is having strong relationship and bilateral agreements on tax-free
export/import with Russia and CIS countries (Commonwealth of Independent States) mainly ex-
USSR countries - Azerbaijan, Armenia, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia,
Tajikistan, Turkmenistan, Uzbekistan and Ukraine)
Competent Authorities in all the countries are Ministry of Health and Agency for Medicines and
Medical Devices.
Regulatory Requirements – Applicant/Marketing Authorisation Holder (MAH)
It is required by the Laws in each of WBC that there must be established local legal entity having
registered address in the country and recorded in official Register of Companies at that country –
LLC company or Representative office of the foreign company in order to be allowed to act as the
Applicant for MAA, and after MA granting, as MAH.
MAH is responsible for quality, safety, efficacy and availability of medicines on the market for
Lecture /
which it is holding MAs. Also, MAH is fully liable for any adverse reactions and or harmful
Presentation
Summary accidents and/or damages that may be caused to patients.
Applicant/MAH must fulfil additional requirements in regard to employees – there must be
employed 2 permanent, full-time responsible persons, graduates from the Faculty of Medicine,
Dentistry or Pharmacy:
• person responsible for pharmacovigilance
• person responsible for documentation in the process of obtaining the marketing
authorisation, its variations and renewals
In some cases MAH must have the person responsible for batch release. Batch Release must be
performed by QP which must fulfil specific requirements like in EU. QP cannot be the same as two
above persons. QP could take one of these two roles but not both. MAH must have full-time &
permanent employment contract with the QP and is not allowed to outsource QP duties. In the
special cases when MAH in Serbia is agent of the EU MAH (having contract with EU MAH) and if
there is in place technical agreement between Serbian Applicant/MAH and EU BR (Batch Release)
site and EU QP, for such cases, batches for Serbia could be released by EU QP.
Regulatory Requirements - Content and Format of the Dossier
CTD (paper hardcopy) Format Registration Dossiers in line with ICH and EU guidelines are the
must. Electronic submissions in NeeS format (e-CTD is not accepted) are required in BiH, only.
EU Directives and Guidelines in the scope of quality, safety (non-clinical) and efficacy(clinical) for
medicines for human use, as well as for BA/BE studies, are implemented completely and harmonized
with the latest EU advices, EMA recommendations, instructions and requirements. CTD Modules 2
to 5 must have exactly same format and content as for EU registrations.
Main source of information related to technical requirements for Registration Dossiers for medicines
for human use is as for EU – web site of European Commission – EUDRALEX, Volumes 1, 2B, 3,
4, 9 and 10.
There are specific detailed provisions covering requirements on content and format of Dossiers for:
• Ordinary (chemical) medicines
• Biological Medicines
• Immunological Medicine
• Advanced Therapy Medicines
• Blood and Blood Plasma Medicines
• Radiopharmaceuticals
• Herbal Medicines
• Traditional Medicine and Traditional Herbal Medicine
• Homeopathic Medicines
The most of the above provisions are completely harmonized with relevant EU requirements.
DMF or ASMF for API is accepted (as CTD 3.2.S format - Closed and Open part). DMF Closed part
is submitted to Agencies directly by API manufacturer. EU CEP is preferred for API. QP Declaration
must also be available for API site.