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무역관 담당자 정보

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
Organization Pharmillennium Consulting d.o.o.
(Brief Description)

Current Position CEO

Crvenih mornara b.b., Đenovići (Montenegro)

Cara Uroša 17/1st Floor, 11.000 Belgrade, Serbia


2000 – Present CEO / Pharmillennium Consulting

 Along to complete duties and role of the CEO, project teams leader, pharmaceutical and
healthcare system expert, whole range of responsibilities in the scope of management of
the company including negotiations, HR management, executive operations, finances,
legal issues, accounting, tax issues, on-shore and off-shore operations, corporate set-up
and structuring, business structuring, business planning, marketing and promotion issues,
contracting and sub-contracting, customer and public relations, development of consulting
services in Healthcare systems and pharmaceuticals, medical devices and food
Biography supplements manufacture, warehousing, marketing, promotion and distribution.
 Organization, management and lecturing at seminars and training courses in the scope of
ICH, EU, WHO and national regulations, as well as GMP, GDP and other. Project
development, team management, and implementation of whole range of GxP, ISO,
HACCP standards and guidelines.
 Compiling dossiers, registration and licensing of medicinal products and medical devices
and expert consulting services in the scope of Regulatory Affairs. Team leadership, project
management, business cases development and implementation, negotiations with
customers, providers, authorities. Development of IS (information systems and databases)
in the scope of medical laboratories, hospitals, quality control laboratories and
pharmaceutical manufacture, etc.
 Broad range of various pharmaceutical expert consulting services for national and
international pharmaceutical companies and regulatory bodies worldwide: West Balkan
Countries (Serbia, Montenegro, Bosnia and Herzegovina, Macedonia, Kosovo, Albania),
EU countries, Middle East and GCC, China, India, etc.
1989 – 2000 Deputy General Director, Head of Laboratory, QA & Information Systems and
Professional Methodology Departments / Institute of Pharmacy of Serbia (currently Agency for
Medicines and Medical Devices of Serbia)
 As the member of the Board of Directors, executive responsibilities for the main
professional operations of the National Control Laboratory including planning,
development, organization, IS development and implementation, HR planning and
management, resources management, equipping, maintenance, day-to-day operations,
relations and contacts with customers, manufacturers and regulatory bodies, management
of professional commissions and internal working groups, development of QA system and
implementation, reporting.
 As the NCL senior manager, participated to regulation set-up and development of
Medicines Law and of Books of regulations. Involved and managed few working groups
and committees at the Ministry of Health of Republic of Serbia covering medicines supply
and procurement, reimbursement policy set-up, strategic planning of supplying of
medicines, development of the general information systems etc.
 Participated to, as the inspection team member, a few GMP on-site visits of pharmaceutical
manufacturers in Serbia, Montenegro and in some EU member states.
 Managed/involved in laboratory operations in Biology, Microbiology and Virology and
Chemical Laboratory in connection to routine QC and registration procedures and
laboratory testing of samples. Authorized and responsible to release medicines for the
federal state market as Head of Laboratory Department of the Institute of Pharmacy of
Serbia in charge of NCL. As manager responsible for whole work of Instrumental
Laboratory, for development of QA system and IS. Expert adviser before court regarding
 Direct practical experience in contemporary instrumental methods for the quality control
of medicines, medical devices, and herbal drugs.
 Experience as the expert for the assessment of Registration documentation and laboratory
quality control of samples submitted for the registration procedure for medicines, medical
devices and herbal drugs.
 Direct responsibilities for the release of the imported batches of human medicines and
medical devices and for issuing the NCL’s Certificates of Analysis.
Outline of Presentation:
Title : Regulatory Framework for Pharmaceuticals in Serbia and West Balkan Countries (WBC)

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
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.

Regulatory Requirements – GMP requirements

Each of countries has own regulation for GMP, but in practice all are favouring existence of EU
GMP Certificates. None of the countries in WBC is PIC/S member.
Both API and Final Product manufacturers must have valid national GMP Certificates, as well as
EU or PIC/S Certificates.
PIC/S Certificates in the last years become equally treated by WBC Agencies and applicable for
registration, as it is with EU GMP Certificates
National GMP Certificates issued by authorities of non-EU, and non-PIC/S countries are not
Regulatory Requirements - National Specificities
Each of countries has own requirements regarding M1 (Administrative data) and own Application
Forms (AF) and list of Appendices to AF, as well as specific requirements regarding PI texts (PIL,
SmPC, Labelling Forms and Mock-ups) in national language.
Additional specific requirements would be presented using example with M1 and administrative data
as required in Serbia.
M1 in Serbia should include additional documents:
• Copy of the Serbian MAH Company’s Incorporation Certificate issued by Register of
Companies in Serbia
• Agreement on technical cooperation between the MAH and Applicant
• Curriculum Vitae of the responsible person for documentation and the Authorization for
communication with the Agency
• Manufacturing Licenses for all the manufacturing sites (API and FP) and confirmation if
more than one place for the release of a batch of medicine
• Flow chart between different manufacturing sites involved in the different manufacturing
processes in the production of one medicine starting with API, up to Batch Release site
• A copy of the API DMF/ASMF, a copy of the written consent of the manufacturer of the
active substance in respect of each change in DMF, or a copy of the Certificate of
Conformity (CEP) with monographs Ph. Eur. (European Pharmacopoeia).
• CPP (original) must be issued within not longer than 1 year before application date
• GMP Certificate for API (original or notarized copy) or GMP Inspection report not older
than 3 years (original or notarized copy) GMP should be valid in the moment of application.
GMP Certificate must be issued by EU or USA FDA or PIC/S authorities. National
authority GMP Certification API site is acceptable only if there is EU manufacturer issuing
QP Declaration and having GMP Inspection Report issued by EU QP or by properly
contracted, certified independent auditing body working for EU QP.
• GMP Certificate for FP (original or notarized copy) or GMP Inspection report not older
than 3 years. GMP inspection report must be original or notarized copy. It is necessary for
GMP Certificate or GMP Inspection report (for both API and FP) be translated in English
and translation must be certified (if original issued in language other than English) . GMP
Certificate must be issued by EU or USA FDA or PIC/S authorities. Local authority GMP
Certification (out of EU) is acceptable only if there is EU MAH or EU BR (batch
release/certification) site issuing QPD and having GMP Inspection Report issued by EU
QP or by properly contracted, certified independent auditing body working for EU QP
• Letter of Access / CEP
• Statement of Commitment. It includes 3 statements:
1. Statement on the identical versions - paper and on CD
2. That identical documentation was approved in CP, DCP or MRP in EU
3. Statement on BE studies – where applicable
• TSE certificate / TSE statement (for active substance and final product)
• CoAs of Samples and Standards
• Samples and Chemical Standards (API and impurities)
• QP declaration that API is manufactured in accordance with GMP. This declaration must
be issued by QP which responsible for final product batch release in Serbia. EU QP may
release batches for Serbia if specific conditions are satisfied
• Marketing Approval in the Country of Origin (MA in the country from where the product
is intended to be exported to Serbia - country of origin)
• Marketing Approval in EU Countries (if country of origin is other than EU)
• Mock up proposal in Serbian language
• Information about experts – quality
• Information about experts – non-clinical
• Information about experts – clinical
• Module 1.5. Specific requirements for different types of applications
• Environmental Risk Assessment
• Pharmacovigilance DDPS
• Information related to clinical trials - M1.9 Information relating to Clinical Trials
According to Article 8 (ib) of Directive 2001/83/EC a statement to the effect that clinical
trials carried out outside the European Union meet the ethical requirements of Directive
2001/20/EC should be provided, where applicable. This statement should indicate that
“clinical trials carried out outside the European Union meet the ethical requirements of
Directive 2001/20/EC” together with a listing of all trials (protocol number) and third
countries involved. The requirement applies to all new applications (including extension
applications), and other relevant post-authorization regulatory procedures (e.g. variations)
for which clinical trial reports are submitted.
• PSUR (initial recommended 5 yrs data)
• Statement on application of EU HBD DLP PSUR scheme (if applicable)

Regulatory Requirements - Procedures

The only registration procedure available for all the countries is – National MAA. There is no
common procedure for registration set between those countries. Also, it is not possible to use EU
MRP or DCP, or CP procedure schemes. Although, in most of countries there are provisions set by
the national regulations enabling shortened duration of the registration procedure for products having
MA in EU, especially for those medicines which were granted EU MA in CP or DCP procedure.
Specific requirements for the National registration procedure would be presented using example with
applicable terms and timelines in Serbia.
There are specific provisions covering National registration procedures for:
• Regular procedure for registration of human medicines (30+210 days in Serbia)
• Accelerated procedure for registration of human medicines (30+150 days in Serbia)
o medicines of the highest interest for public health protection, but above all,
therapeutic innovation (i.e. some vaccines, or some innovative products etc.
coming from non-EU countries which could not fulfil point 2 below. This usually
apply to i.e. USA, Canada, Japan products)
o medicines having MA issued in EU following CP.
• Conditional Marketing authorisation valid 12 months and reassessed each 6 months - for
medicines used to treat, prevent or diagnose serious and life-threatening diseases, used in
emergency cases, used to treat rare diseases, medicines having MA issued in EU following
CP, as well as for other medicines of greater public health interest (usually since lack of
clinical data for innovative products)
• Marketing Authorisation under Special Circumstances - for a medicines of special public
health interest – valid for 12 months and with binding the applicant to fulfil the obligations
related to the medicine safety within defined term and timelines
Evaluation of the submitted MAA and Registration Dossier is executed in 2 phases:
1. Assessment of formal completeness (related to M1 data)
2. Through assessment of the M2-M5
In the first phase, after MAA submission, the Agency is obliged to perform a formal assessment of
the documentation for the marketing authorisation within 30 days after the application has been
If the application is incomplete, the Agency shall notify the applicant to complete the application
with the application data, within 30 days from the day the written notice has been received at MAH.
After MAA is defined as formally complete and info is delivered to MAH, The Agency begins the
second evaluation phase:
Within the period of 210 days, after receiving the complete application, the Agency decides whether
to grant a marketing authorisation or deny a marketing authorisation application, based on the
opinions and evaluation of the documentation on medicinal product quality, safety and efficacy,
provided by the Agency Commission.
Marketing authorisation is valid for five years, starting from the date the decision to grant the
marketing authorisation is made,
Marketing authorisation is issued for a particular strength, pharmaceutical form and packaging of
the medicinal product.

Conclusion: Global harmonisation of regulations and technical requirements for registration of

medicines for human use with ICH process is affecting each of countries in Europe, irrespective if
are EU member states or not. Serbia and WBC are following the EU regulations and are interesting
territory for gaining very useful experience in evaluation of the medicines manufactured by Korean
manufacturers, going to strong, developed and rich markets of EU, USA and also interesting
emerging markets of the world
Reason to
Other Details