Tuesday, September 26 2017 13:34
Alexandr Avanesov

The regulatory documents of the EEMP for medicines include about 70% of business proposals

ArmInfo. The development of a single drug market in the Eurasian Economic Union (EAGE), launched in May this year, and the provision of safe, effective and high-quality medicines to allied countries require synergy between national pharmaceutical enterprises and effective communication policies at all levels. Of particular importance, according to Oksana Plashkova, Deputy Director of the Department for Technical Regulation and Accreditation of the Eurasian Economic Commission (ECE), has the organization of business interaction with regulatory and supervisory authorities. "About 70% of the proposals that came from the representatives of the pharmaceutical community to the Commission were included in the normative acts regulating the unified drug market of the EAEC," Oksana Plashkova emphasized.

During the working meeting of the representatives of ECE and a number of leading pharmaceutical companies that are members of the Russian Union of Professional Pharmaceutical Organizations, it was noted that effective interaction of the Commission with business and national regulators allowed creating a balanced system of supranational regulation of medicines with clear and transparent rules.  "The agreement on common principles and rules for the circulation of medicines within the framework of the EAEC and all the main acts of the Commission aimed at its implementation have been adopted and entered into force," Oksana Plashkova noted.

At the same time, transitional periods are provided ensuring a smooth transition from national to unified regulation. In particular, until December 31, 2020, the manufacturer has the right to choose by which rules (national or uniform) he will register medicines. All medicines that have been registered under national regulations before December 31, 2020, must be re-registered under the rules of the single market until December 31, 2025. When submitting a dossier for drug registration until December 31, 2018, the manufacturer is entitled to provide, in place of the EAEC GMP certificate, national documents issued by the member states of the Union and confirming the conformity of its production with the requirements of the national GMP rules. This will help manufacturers of medicines to adapt to new requirements as comfortably as possible.  The regulators of the general market of medicines face an important task - to create optimal conditions for their production in the EAE, which will allow manufacturers to work in the conditions of proper practices, thus ensuring the introduction of advanced technologies and modern standards of treatment.

One of the goals of the working meeting was the awarding of the ECE Prize to the winner of the Eurasian Communications-2017 competition, which the Commission organized jointly with the Business Council of the Eurasian Economic Union and the Russian Public Relations Association. In the nomination "Single Market of Medicines", Bayer AG won the victory. The pharmaceutical company presented a project systematically combining the issues of launching new drugs in the unified market of the Union and the strategy of information support of this process, including the development of multimedia products, the creation of a common package for the countries of the Union for Packaging Design, taking into account the linguistic diversity and the requirements of the standards and technical standards of the EAPS. The creation of a unified communication platform and the development of a new business model for interaction with consumers and regulatory agencies of the EEA countries became one of the key arguments for awarding the company the first place in the nomination.  

POST A COMMENT
Input digits     


News
Armenian ambassador to Greece highlights importance of Armenia`s  active participation in TIF-HELEXPOArmenian ambassador to Greece highlights importance of Armenia`s  active participation in TIF-HELEXPO
Air Arabia plans to sue Armenia at ArbitrationAir Arabia plans to sue Armenia at Arbitration
EFSD conducts workshop on procurement and financial management of  projects EFSD conducts workshop on procurement and financial management of  projects 
Iran-Armenia high-voltage line to be put into operation in few months  - ambassadorIran-Armenia high-voltage line to be put into operation in few months  - ambassador
New Armenal management could start presale preparation New Armenal management could start presale preparation 
Our team is doing everything possible to manage increased traffic  more efficiently - ZvartnotsOur team is doing everything possible to manage increased traffic  more efficiently - Zvartnots
CBA to direct 80% of its annual profit to partly cover interest-free  bill of exchange  CBA to direct 80% of its annual profit to partly cover interest-free  bill of exchange  
Few concerned in Armenia over high pesticide level in food - NGO head Few concerned in Armenia over high pesticide level in food - NGO head 
Head of Economic Competition Protection Commission explains gas price  rise Head of Economic Competition Protection Commission explains gas price  rise 
EFSD to provide $2 mln grant to Armenia for program to improve  quality of financial reporting of public sector organizationsEFSD to provide $2 mln grant to Armenia for program to improve  quality of financial reporting of public sector organizations
WB to provide $110mln loan to Armenia for universal health coverage WB to provide $110mln loan to Armenia for universal health coverage 
Ingo Insurance presents job loss insurance in Armenia`s market Ingo Insurance presents job loss insurance in Armenia`s market 
As long as Pashinyan government remains in power in Armenia, it is  unlikely Armenia will launch a counter bid or join BRICS  - opinion As long as Pashinyan government remains in power in Armenia, it is  unlikely Armenia will launch a counter bid or join BRICS  - opinion 
Cattle productivity improvement programme to be launched in Armenia Cattle productivity improvement programme to be launched in Armenia 
South Caucasus needs unified market without strategic partners -  expert South Caucasus needs unified market without strategic partners -  expert 
New world order to show Armenia can and must cooperate with with all  nations - Tatul Manaseryan New world order to show Armenia can and must cooperate with with all  nations - Tatul Manaseryan 
Armenia needs 600MW NPP - ex-premier Armenia needs 600MW NPP - ex-premier 
Post of Russia considering possibility of mailing to Armenia via  North Ossetia  Post of Russia considering possibility of mailing to Armenia via  North Ossetia  
Advantages of franchising discussed in Armenia with Acba Bank`s  participation Advantages of franchising discussed in Armenia with Acba Bank`s  participation 
Czech Republic to assist modernization of Yerevan metro Czech Republic to assist modernization of Yerevan metro 
Wine output records 32.6% y/y decline in Jan-May Wine output records 32.6% y/y decline in Jan-May 
ICC NCA to assist organization of WCIT2024 in Armenia ICC NCA to assist organization of WCIT2024 in Armenia 
New social vulnerability assessment system to be introduced in  Armenia New social vulnerability assessment system to be introduced in  Armenia 
Armenia`s government to provide AMD 2.2bln to construction  organizations Armenia`s government to provide AMD 2.2bln to construction  organizations 
AMD 4․046․161  to the Strong Mind NGO. July`s beneficiary is the SIA Armenia programAMD 4․046․161 to the Strong Mind NGO. July`s beneficiary is the SIA Armenia program
Wine-filled days of DILIJAN WINE FEST 2024 will take place on August 3 and 4Wine-filled days of DILIJAN WINE FEST 2024 will take place on August 3 and 4
Ardshinbank was again Named Best in Two Categories by Asian Banking & Finance MagazineArdshinbank was again Named Best in Two Categories by Asian Banking & Finance Magazine
Some 20,000 Nagorno-Karabakh Armenians employed in Armenia - official Some 20,000 Nagorno-Karabakh Armenians employed in Armenia - official 
China Southern Airlines launches Urumqi - Yerevan - Urumqi flights China Southern Airlines launches Urumqi - Yerevan - Urumqi flights 
Get 3000 idcoins by synchronizing your Idram and IDBank accountsGet 3000 idcoins by synchronizing your Idram and IDBank accounts
Armenia`s involvement in regional projects emphasized Armenia`s involvement in regional projects emphasized 
Armenian Airlines launches Yerevan-Ufa-Yerevan flightArmenian Airlines launches Yerevan-Ufa-Yerevan flight
Unemployment up in Armenia Unemployment up in Armenia 
Armenia`s economy vulnerable to external shocks - EFSDArmenia`s economy vulnerable to external shocks - EFSD
EAEU Industrial Council considers robotics development programme EAEU Industrial Council considers robotics development programme 
Smart Place: smart solutions for comfort and energy-savingSmart Place: smart solutions for comfort and energy-saving
Russia among Armenia`s major trade partners - Gevorg Papoyan  Russia among Armenia`s major trade partners - Gevorg Papoyan  
Armenia, UAE discuss possibilities of agricultural cooperation Armenia, UAE discuss possibilities of agricultural cooperation 
Expert on `blank spots` of budget planning in Armenia Expert on `blank spots` of budget planning in Armenia 
Armenia`s economy minister to take part in 6th meeting of EAEU  Industrial Policy CouncilArmenia`s economy minister to take part in 6th meeting of EAEU  Industrial Policy Council
No payment via Idram? More than 21,000 points of sale accept payment via IdramNo payment via Idram? More than 21,000 points of sale accept payment via Idram
<Gazprom Armenia> will conduct a survey of underground gas pipelines  with a total length of over 335 km will conduct a survey of underground gas pipelines  with a total length of over 335 km
WB to issue grant to Armenia for environmental protection programmes WB to issue grant to Armenia for environmental protection programmes 
JFPR to issue $3mln grant to improve rural household resilience JFPR to issue $3mln grant to improve rural household resilience 
EBRD to issue EUR 2mln grantfor Syunik customs center  EBRD to issue EUR 2mln grantfor Syunik customs center  
Armenia, Georgia discuss possible implementation of regional  high-tech projects Armenia, Georgia discuss possible implementation of regional  high-tech projects 
Ameriabank and COAF Pool Efforts to Develop Beekeeping in Lori RegionAmeriabank and COAF Pool Efforts to Develop Beekeeping in Lori Region
Deputy Minister of Economy: 58% of Armenia`s agro-food products are  exported to Russian marketDeputy Minister of Economy: 58% of Armenia`s agro-food products are  exported to Russian market
Armenia`s scores are the worst in the Energy Transition Index for the  last decade: LUYS FoundationArmenia`s scores are the worst in the Energy Transition Index for the  last decade: LUYS Foundation
Features of Armenian offshore: SRC assesses lossesFeatures of Armenian offshore: SRC assesses losses
Trend of shadow economy is reducing; Rustam Badasyan assuresTrend of shadow economy is reducing; Rustam Badasyan assures
Tax revenues on schedule in Armenia Tax revenues on schedule in Armenia 
Ball is in US court - Armen Grigoryan on NPP construction Ball is in US court - Armen Grigoryan on NPP construction 
The construction of the Pullman International Hotel complex in Armenia will cost 100 million US dollarsThe construction of the Pullman International Hotel complex in Armenia will cost 100 million US dollars
World Bank does not change Armenia`s status as upper-middle-income  countryWorld Bank does not change Armenia`s status as upper-middle-income  country
Armenian banks` delegation visits OVIO Data Processing CenterArmenian banks` delegation visits OVIO Data Processing Center
In-country tourism recorded 20% average annual growth since 2020 In-country tourism recorded 20% average annual growth since 2020 
Araratbank allocates $10 million in funding to women entrepreneursAraratbank allocates $10 million in funding to women entrepreneurs
State Revenue Committee reminds taxpayers of tax bill deadline State Revenue Committee reminds taxpayers of tax bill deadline 
Powers of Armenia`s Economic Competition Protection Commission to be  expanded Powers of Armenia`s Economic Competition Protection Commission to be  expanded 
Read more
Exchange rates
19.07.2024
RUB4.420.02
USD388.370.38
EUR422.70-1.49
GBP501.81-2.19
CAD283.15-0.51
JPY24.66-0.15
CNY53.43-0.01
CHF436.67-2.38