Bureau Cracy: regulatory affairs on medicinal products, medical devices, BAS

Cratia Ltd. has created a new online portal that is devoted to the state registration in Ukraine of the medicinal products and pharmaceutical substances, medical devices, biological and dietary food supplements, cosmetic products.

New website includes more than 120 unique pages, news, references on the current legislation, analytical reviews and publications.

State Pharmacological Center MOH of Ukraine performed deep analyses of the harmonization status of Ukrainian legislation in the field of registration of medicines towards European Union (Directive 2001/83/EC, Directive 2003/63/EC, Directive 2004/27/EC). In accordance with results of analysis following changes to current Ukrainian legal acts are suggested:

- adoption of “List of referent products that could be used during compare studies (BE, BA)”;

- minor corrections regarding required documents for radiopharmaceutical products;

- determination of requirements to experts on chemical, pharmaceutical, pharmacological, biological, preclinical and clinical reports;

- detalization of terms and procedure of registration of medicinal products with well-established use, similar medicinal products of biological origin, fixed combinations, traditional medicinal products;

- harmonization of registration procedure of medicinal products of biological origin, orphan drugs;

State registration of medicinal products, medicines, pharmaceutical products in Ukraine. Marketing authorization of medications, remedies, pharma products. Regulatory affairs legislation of health and medical products. Ukraine, Kiev, Cratia Ltd.

Regulatory system of Ukraine in the field of medical devices will be represented in Tarius database

Cratia Ltd. has became preparation of the analytical review for Tarius Database (Schultz Group, Denmark) of Ukrainian regulatory system in the field of marketing authorization, custom management, sales and marketing of medical devices. Detailed guidelines, law cites, explanations and advices will be presented in 21 Summaries.

Expected finish of the preparation procedure is end of February – beginning of March 2008.

Marketing license and state registration of medical devices, health instruments, healthcare equipment in Ukraine. Regulatory affairs on medical devices, approval of marketing permission on medical device. Ukraine, Kiev, Cratia Ltd.

Starting from 01.02.2008 the obligatory requirement for marking (package imprint) of medical devices with special graphical symbols comes into force. Mentioned requirement is implemented by Order of the State Committee of Ukraine In the field of technical management and consumer policy No 294 as of 01.11.2007. Marking of medical devices should be perfomed in accordance with national standard SSTC (DSTU) EN 980:2007 “Graphical symbols for marking of medical devices (EN 980:2003, IDT). Standard was developed for harmonization of regulatory requirements and in accordance with standard of EU “EN 980:2003”.

Both domestically and imported medical devices should comply with mentioned standard.

Please accept our warmest wishes on New 2008 Year and Christmas from Cratia Ltd.! We wish you strong health and let all your wishes will come true!

In accordance with information from State Authority of medicinal products and medical devices, starting from 2005 there was issued 526 certificates of compliance with Good Manufacturing Practice (GMP) of foreign manufacturing sites of medicinal products. Procedure of the recognition of GMP certificate is performed in accordance with Order of the MOH of Ukraine №391 dated 30.10.2002. According to the Decree of Cabinet of Ministers №902 dated 14.09.2005, medicinal products manufactured by GMP-recognized manufacturer are free from every-batch quality control. Besides, certificate of recognition of GMP compliance is the obligatory requirement to participate in tenders (budget purchasing) in accordance with Decree of Cabinet of Ministers №252 dated 07.03.2006.

In accordance with official information of the State Pharmacological Center of Ministry of Health of Ukraine, 10220 marketing authorizations (registration certificates) are valid in Ukraine at 18.09.2007 for the finished medicinal products, 885 market licenses for medicinal products in-bulk, 1100 of the registration certificates for active substances.

Domestically manufactured finished medicinal products are 31,77% (3247 products accordingly), imported medicinal products are 68,23% that is equal to 6973 registration certificate.

Experts of Cratia Ltd. were invited by Journal of Medical Device Regulation (UK) to perform the analytical review of the Ukrainian regulatory system of medical devices. Our article will be presented in Journal of Medical Device Regulation at November 2007.

At 10 th of September 2007 Cratia Ltd. has finished first stage of the cooperation with Tarius A/S ( Schultz Group , Denmark ) in the field of representing information about Ukraine in the international regulatory database of Tarius. In accordance with agreement, Cratia Ltd. have developed all required parts of the informative-analytical database of Tarius in term. Thus, regulatory-approval system of Ukraine is presented by:

We truly believe that performed work will endow development of the Ukrainian pharmaceutical field and will positively influence the image of our country.

At 17 th of August 2007 Ministry of Justice of Ukraine has adopted Order of MOH of Ukraine №190 dated 17.04.2007 “About approval of the order of evaluation of additional studies on the medicinal products during expertise of the registration materials”. That Order was developed by experts of State Pharmacological Centre of Ukraine (SPhC) and will come into force at 28 th of August 2007.

At 3 rd of July 2007 a cooperation agreement between Cratia Ltd. and Danish company Tarius A/S was achieved. Traius is specialized in the field of informative supply of regulatory departments of medical and pharmaceutical companies, main product is entire overwhelming database of the legislation, particularities and guidelines of state registration and product marketing and have the following main chapters:

National authorities: Scope of activities, structure, role and functioning
National industry associations
National Fees: system, procedure of payment and amount of State fees
Drug development: Scientific advice, Clinical studies
Marketing authorisation of medicinal products: format and content of applications , e lectronic submissions, packaging and labeling requirements, orphan drug designation, compassionate use
Import of products, manufactured in foreign countries: data protection and generic medicinal products
Maintenance of marketing authorizations: variations, renewals, withdrawals, line extensions, transfers, OTC switch
Pricing and reimbursement
The post marketing period: adverse event reporting, advertising, inspection of manufacturing sites, s ale to consumers

Database include general legislation of the European Union, legislation and particularities of the every separate country – member of EU, Australia, USA and Canada, Russian Federation, South America countries, Africa, China, Japan, India and almost all other countries in the world, news of EMEA and FDA. Database is a powerful informative-analytical instrument that is used by many pharmaceutical companies that expand to the external markets, as well as by government officials of the regulatory authorities of different countries.

In accordance with achieved agreement, Cratia Ltd. will represent Ukraine in the Tarius database. At the first stage of cooperation Cratia Ltd. will prepare the detailed reviews of every key chapter, respective legislation.

Second stage include everymonth control and update of the reviews and legal acts.

Expected term to finish the first stage of cooperation is the end of August – beginning of September 2007.

In the last year Ukrainians spent for purchasing of the medicines more than $1,5 billion.
In 2006 the total volume of the retail market (pharmacies) was over 1,5 billions US dollars. Market was presented by 483 foreign and 184 local manufacturers, which offered more than 9000 of the medicinal products and bio active supplements.
In the next year total growth of the pharmaceutical market (medicinal products plus supplements) is expected at the level of 25-30% with simultaneous growth of the prices as 10-12%. Additionally, it also expected that Ukrainians will prefer more expensive, but quality medicines.

Name	Country	Therapeutic effect	Price, USD
Actovegin	Australia, Norway	Activisation of the cells	Ampoule 5 ml: 3,0 - 3,1 50 tablets: 38,0 – 40,0
Essencialle Forte N	France	Treatment of liver diseases	30 capsules: 7,0-7,5
Viagra	USA	Erectile dysfunction	1 tablet: 13,5-14,0
Mildronate	Latvia	Activisation of the cell metabolism	40 capsules: 6,5-7,0
No-Spa	Hungary	Anesthetizing and spasmolytic action	20 tablets: 5,1-5,4

Name	Country	Therapeutic effect	Price, USD
Cipgan	Russian Federation	Strengthening of immunity	30 capsules: 5,0-5,5
Ocuvait Lutein	Germany	Improvement of sight	60 tablets: 13,0-13,4
Striks	Denmark	Improvement of sight	30 tablets: 9,2-10,0
Ideal	Russian Federation	Weight reduction	60 tablets: 18,3
Spasatel Forte	Poland	Acceleration of healing of wounds	1 Tube: 8,0-10,0

31.12.2006. Happy New Year!
Dear colleagues! We wish you in the New 2007 Year a strong health, growing wealth, luck, happiness and success in all your intentions. Let the New Year will bring new great results and let all your wishes will come true.
With warmest regards,
Team of Cratia Ltd.

17.09.2006. Day of the pharmaceutical worker.
Collective of the Bureau "Cratia" warmly congratulates all colleagues with a professional holiday - Day of the pharmacist and wishes all experts and workers of branch a strong health, happiness, mutual understanding, harmony in family and in collective and amicable joint activity for blessing of the human health!

01.08.2006 Session of the State Pharmacological Center in August.
We inform that there will be no session of SPC in August due to the mass vacations of state employees at the summer period.

15.06.2006 Head of the State Service has been appointed.
Cabinet of Ministers of Ukraine at June 7, 2006 has appointed Mr. Yriy Konstantinov to the post of the Head of State Service of medical devices and medicinal products of Ukraine.

17.05.2006 Detailed scheme of the registration process (medicinal products).
Our specialist created a Presentation to show you in details the procedure of registration of medicinal products in Ukraine with our assistance. Presentation includes management, negotiation, correspondence and financial aspects.
That presentation will be very useful for those managers who are interested in registration of medicinal products, have no experience in Ukraine and in cooperation with us, and wish to obtain more information on that issue.
Presentation (in MS PowerPoint) can be downloaded here (currently only Russian version is available, English is coming soon).

11.05.2006 Contacts.
Our contacts has slightly changed (telephone number) for the reason of recent telecommunication problems. Our new telephone number you can get at "Contacts" page.

05.05.2006 Official seminar on Registration of medicinal products.
At 8-9 of June 2006 there will be a seminar devoted for new legislation in regulatory affairs on medicinal product in Ukraine. Seminar will take place in Odessa city, hotel complex “Viktoriya”. Seminar will be led by Director of the State Pharmacological Center (SPC) Mr. Viktor Chumak, depute director of SPC Ms. Tatyana Buhtiyarova, director of the Clinical Studies department Mr. Viktor Maltsev and so on. Following questions will be discussed during seminar:

Full text of the seminar (in Ukrainian language) you can download by clicking here.

04.04.2006 Only products with confirmed quality can participate in State Tenders in Ukraine.
To prevent purchasing of cheap, but unquality or falsified medications for budget funds, Ministry of health of Ukraine developed, and Cabinet Ukraine accepted Decision dated 06.03.2006 № 252 "Order of the use of funds in 2006, foreseen in the State Budget for implementation of the centralized healthcare measures and programs".
That decision defines, that in the case of purchase of medications of foreign production for budget funds, one of the requirements is a presence for the manufacturer of GMP confession (recognition) certificate, issued by State service of medicinal products and medical devices of Ukraine.
You can obtain more information on the procedure of GMP-confession you can proceed to the corresponding page of our website or by clicking here.

27.03.2006 Order #220 will stay in force till 01.01.2007.
We received information from SPC that till 01.01.2007 two laws on registration of medicinal products will stay in force:

That mean that Applicant can decide whether to submit Application and dossier in old or new structure; depending on Application form procedure will also differ.
Such situation with regulatory affairs, as we suggest, was caused by weak legal base of legislation.

07.03.2006 Legislation on registration of medicinal products in English language.
New information on our website – English texts of Ukrainian legislation on regulatory affairs on medicinal products:

02.03.2006 Changes in registration process of immunobiological products.
Today the list of changes to the Order #486 of registration of immunobiological products was finalized and document was transferred to the Ministry of Justice of Ukraine for adoption.
We define the following major changes:
► Responsible state authority changes from “Center of imunobiological products” to “State Service of medicinal products and medical devices”.
► Minor changes to the dossier and procedure.
From our point of view adoption of the changes to the current order will cause the 3-5 month delay in registration of IB products since new authority do not have enough resources now to perform the registration procedure.

02.03.2006 AIDS in Ukraine.
In accordance with information from “Human Rights Watch”, there are 416 000 of inhabitants of Ukraine are infected with AIDS (1,6% of total population of Ukraine).

04.01.2006 New legislation came into force.
Starting from 01.01.2006 registration of medicinal products and substances is being regulated by Order # 426 of Ministry of Health of Ukraine.
We define the following major changes:
► Application became much more complicated; now it consist from 15 pages and became a “micro-dossier”. Points regarding confession of GMP and every batch control are included to Application.
► Term and definition of generic product has changed;
► Registration of well-known (more than 15 years on the market) medicinal products became easier;
► Variation procedure became much more complicated; any changes in composition in part of active ingredients cause the new registration procedure;
► Maximum terms for each step of registration defined:
a) expertise of the dossier of medicinal products applied for registration – 7 months from the day of submission of Application;
b) expertise of the substance applied fro registration – 3 months from the day of submission;
c) expertise of the dossier of medicinal products applied for re-registration – 3 months from the day of submission;
d) expertise of the dossier of medicinal products applied for variation type I or II – 2 months from the day of submission;
Important: mentioned above period do not include delays caused by answers on comments, additional expertise, quality assurance in laboratory (plus 1-3 month to every point).
Download the full text of new Order and Annexes to it (RAR archive).
If you are interested in our services during registration procedure – you can find additional information here.

01.01.2006 New year!
Dear colleagues, from the name of Bureau “Cratia” we wish you strong health, success in all you intentions, prosper and joy in New 2006 Year!

11.01.2006 Information from MOH
At year 2006 following funds are going to be spent from State Budget:
► State sanitary-epidemiologic and disinfector issues – 106,74 millions USD (126% from 2005);
► Issues related with AIDS and Tuberculosis – 29,26 millions USD (142% from 2005);
► Blood testing on hepatitis B and C – 2,54 millions USD.
► Epidemics – 1 million USD;
State program “Water of Ukraine” on 2006-2020 years: more than 1 billion USD;

15.11.2005 First GMP-recognized companies.
At 15th of November 2005 the "State Service of medicinal products and medical devices" issued first certificates of confession of GMP. Two companies were certified – Lilly (USA) Zentiva International a.s (Chez Republic).
If your company is also interested in confession procedure - you can find additional information here.

18.10.2005 Order on prescription-only products has been cancelled.
Recently appointed Minister of Health Mr. Yriy Polyachenko has cancelled Order #441 on prescription-only products.

12.10.2005 New Minister of Health.
Yriy Polyachenko was appointed to the post of Minister of Health of Ukraine by Order of President # 1436/2005.

22.09. 2005. List of prescribed products was adopted.
The list of prescribed products was adopted by the MOH at September 22, 2005. Total number of medicines to sale without prescription counts 3091 products, 39% of all medical products registered in Ukraine. Products that will be registered in future will enter the market in accordance with information from instruction (leaflet).

17.09. 2005. Day of the pharmaceutical worker.
Dear colleagues, please accept our congratulations on the occasion of Day of the pharmaceutical worker! We wish you success in all your intentions, many positive emotions, love and an excellent health!

16.09.2005. Condition of the pharmaceutical market of Ukraine.
We offer you brief information based on the acknowledgement of MOH of Ukraine regarding condition of the pharmaceutical market of Ukraine. This acknowledgement consists of statistic information of the MOH and its Departments, Ministry of statistic, etc. You can find the full text in Ukrainian here. More…

10.09.2005. List of prescription-only products. We received the project of the Order #441 “About adoption of the list of products that must be used only with prescription” dated 02.09.2005 (not signed yet) that specifies the area of earlier document - Order of MOH of Ukraine #360 “About the rules of prescription and orders for the medicinal products and devices of medical purpose” dated 19.07.2005. You can find that list here in Ukrainian, .pdf format.

08.08.2005. Government was fired by President.
President of Ukraine, Mr. Yushenko, signed the Order to stop the responsibility of the Prime Minister, Ms. Yulia Timoshenko, and fired the Cabinet of Ministers.

01.07.2005. Information regarding registration procedure.
Dear colleagues, we inform you that due to the summer vacations there probably will no planned session of the State Pharmacological Center in the end of August.

17.06.2005. Day of the healthcare worker.
Dear colleagues! Please accept our invitations with the Day of the Healthcare worker. We wish to all representatives of the most humane profession the excellent health, good wealth, love and positive emotions in your every work day!

28.05.2005. New decision on registration procedure is signed.
Prime Minister of Ukraine, Ms. Yulia Timoshenko, signed the Decision #376 dated May 26, 2005 “About adoption of the procedure and fees for the State registration (renewal) of the medicinal products”. Text of the Decision is available here.

09.05.2005. Market survey.
Market survey on pharmaceutical retail market in the first quarter of 2005 is available for all visitors of our website. We expect that such survey will be useful for marketing purposes of our present and potential customers. More…

03.03.2005. Market survey.
Market survey on pharmaceutical market volume in the 3rd quarter of 2004 in units and USD is available for all visitors of our website. We expect that such survey will be useful for marketing purposes of our present and potential customers. More…