Registration of drugs in Ukraine: procedure, required documents and terms
Almost all drugs are approved for use in Ukraine after their state registration. The only exceptions are medications that are prepared in pharmacies by prescriptions of physicians and medications ordered by prophylactic and medical institutions which are made of active ingredients permitted to use and supplementary ones which are not subject to state registration.
For state registration one must provide an application and a significant set of documents and materials. The application shall include: trade name of drug, active ingredient, activeness (dose), dosage form and packaging, name of the applicant and other data. The form of such application was approved by the Order № 426 of the Ministry of Healthcare of Ukraine dated 26.08.2005 (the list of information that must be specified therein is defined de facto basing on the form).
The same order identifies the most comprehensive list of documents and materials that are required for state registration of a medicinal drug. The following information is among administrative data to be provided:
- A copy of license for drug production or document issued by the competent authority of a country where a manufacturer is located that proves the manufacturer to have the license to produce medical drugs;
- List of countries in which licenses for manufacturing of drugs were issued;
- List of countries where the drug has been registered along with a list of countries where an application for registration hasbenn submitted;
- A copy of: Summary of Product Characteristics (SPC) registered in a country where manufacturer / applicant is located;
- Draft of product brief description;
- Proposed labeling text and text of instructions for medical use;
- Samples of a product;
- Samples and / or models of primary and secondary packaging, labels;
- Information about independent experts;
- Certificate of quality for three production series of a product or one certificate for one series with a commitment to provide certificates for two other series as soon as they become available.
In addition according to the Resolution № 376 of the Cabinet of Ministers of Ukraine dated 26.05.2005 one must provide a copy of document certifying compliance of medical drug which was submitted for registration production conditions with the requirements of good manufacturing practice (GMP) which is in force in Ukraine. According to the letter № 519-1.3/3.2/17-12 of the State Administration of Ukraine on Medicinal Products such documents may include certificate of drug production compliance with current good manufacturing practice requirements in Ukraine or conclusion that certifies conformity of drugs production in Ukraine with current requirements of GMP. Both documents are issued by the State Administration of Ukraine on Medicinal Products in accordance with the Order № 391 of the Ministry of Healthcare of Ukraine dated 30.10.2002. The first document is issued after certification of production by bodies the State Administration of Ukraine on Medicinal Products and the second one as the result of examination of an official document on compliance of drug manufacturing requirements with GMP issued by the competent regulatory authority of the PIC/S member country. However the mentioned Resolution № 376 of the Cabinet of Ministers of Ukraine of 26.05.2005 stipulates that domestic manufacturers as such document provide certified copy of a valid license for production of pharmaceutical drugs.
In addition to listed administrative documents an applicant must submit a number of "medical nature" documents that are required for an expertise. Such documentation is divided into four groups:
- chemical, pharmaceutical and biological documentation of medications (including project production regulations or information on production technology, information about drugs ingredients and methods of output data control, materials on methods of quality control, etc.);
- pharmacological and toxicological tests;
- reports on pre-clinical testing;
- reports on clinical testing.
For some drugs that are subject to registration a part of the abovementioned documents is not required, for others additional documents are required. For example registration of homeopathic medicines and traditional herbal medicines does not required scientific clinical data. And if the product is essentially the same with already registered drug or medical ingredient of such drug, is well studied then an applicant is not required to provide the results of toxicological and pharmacological tests or the results of clinical testing. At the same time registration of drugs containing sources of radionuclide requires additional information and specifications.
For registration of drugs based on or related to the intellectual property objects which are patented one must additionally submit a copy of a patent or license that allows production and selling of registered pharmaceutical drugs. It also must include a letter of guarantee which states that the rights of third party that are protected are not violated in connection to the registration of the drug.
What else needs to be done?
Besides preparing mentioned list of documents the applicant must also pay a fee for the registration of pharmaceutical drugs. The amount of the fee when registering "regular" drug is 100 Euros for each dosage form, 10 Euros for each subsequent dose, 10 Euros for each following package. For registration of radioactive drugs, diagnostic agents, products of blood and plasma, simple or complex (galenic formulation) products of crude drugs, active ingredients of limited use and those produced in accordance with approved specifications of the Ministry of Healthcare of Ukraine applicants have to pay a fee of 25 EUR per one name, 5 Euros for each subsequent dose, 5 Euros for each subsequent package.
According to the Resolution № 376 of the Cabinet of Ministers of Ukraine dated 26.05.2005 in order to register medicines one should first of all submit an application to the Ministry of Healthcare of Ukraine which sends a copy to the State Expert Center (hereinafter - the Center) with a letter for expertise appointment. And only after this all other materials can be sent to the Center. But all the documents are often submitted to the Department of medical products state registration at once as required by the Order № 585 of the Ministry of Healthcare of Ukraine dated 16.07.2010.
Mentioned materials which form the Common Technical Document (CTD) dossier of a pharmaceutical drug shall be submitted in duplicate (if comfortable - in electronic form) in Ukrainian, Russian or English. If the materials are submitted in English their translation into Ukrainian or Russian is required along with additional materials.
After this an applicant must enter into agreement with the Center for examination of registration materials and if necessary - preclinical and clinical testing of drugs. Among other things this agreement stipulates price of expertise the amount of which depends on the type of application.
Conduction of an expertise is stipulated by the Order № 426 of the Ministry of Healthcare of Ukraine dated 26.08.2005. Particularly in accordance with mentioned document first of all the Center conducts a preliminary examination of submitted materials within 15 days after which an applicant receives a written response. Within this expertise the presence of all necessary data and its correctness is verified. If there are any obvious problems an applicant will have 90 days to finalize registration dossier (including the addition of missing materials). If the registration documents of dossier are appropriately prepared the documents will be passed to a specialized expertise.
The total duration of the expertise is 210 days from the date of official acceptance of application for registration of medicines. Term of pharmaceutical drugs that are submitted on the basis of specific types of applications expertise, registration term for active substances and medicines submitted for re-registration is 90 days. But this term does not include the time for finalizing materials by an applicant (for example during the specialized expertise the Center may request additional materials on effectiveness, safety and quality of pharmaceutical drugs which are to be provided by an applicant within 90 days) and duration of additional tests and/or expertise. These additional tests are conducted after payment of their costs under corresponding agreements in accordance with the Order № 190 of the Ministry of Healthcare dated 17.04.2007.
Based on results of the expertise the Center prepares a conclusion on the effectiveness, safety and quality of the product and recommends state registration or refusal. As a ground for negative decision the Center can use data obtained during the expertise about health harmfulness of drugs, their therapeutic inefficiency, inconsistency of their qualitative and quantitative composition, non-compliance of documentation with set requirements, infringement of intellectual property rights of other persons.
Based on the conclusion and recommendations of the Centre the Ministry of Healthcare of Ukraine makes a decision to register a product or deny such registration within a month. The fact of pharmaceutical drug state registration is confirmed by a registration certificate which must be issued within 10 days after the registration of a drug. The maximal validity term of registration certificate is 5 years (it can be reduces upon applicant’s request). After the end of the term further use of the drug is possible only after re-registration.
The comment was prepared by lawyers of law firm “Pravova Dopomoga”.
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