Active pharmaceutical ingredient (drug substance, active substance, substance) (hereinafter referred to as API, active substance, substance) – any substance or mixture of substances intended for use in the manufacture of a medicinal product, and during this process it becomes the active ingredient of the medicinal product. Such substances have pharmacological or other direct effects on the human body. As a part of finished forms of medicinal products they are used for treatment, diagnosis or prevention of disease, for changing conditions, structures or organism's physiological functions, for management, manipulation and relief of symptoms.
APIs may be compacted, film-coated, granulated, grinded/crushed to a certain level or treated otherwise, and presented under different names and in different forms (in particular as pellets, granules and other presentations).
Legislation of Ukraine includes active pharmaceutical ingredients in the general term "medicinal product". For APIs there are a number of significant simplifications, in comparison with finished medicinal products, namely:
- the procedure for registration of APIs is much simpler, cheaper and faster;
- registration of APIs does not require creation and maintenance of the pharmacovigilance system in Ukraine;
- registration and importation of APIs does not require confirmation of compliance (decision on recognition or certificate) of the manufacturing process with GMP requirements;
- quality control of imported substance is not performed by the State Administration of Ukraine on Medicines and Drugs Control (SAUMD), but by the Importer;
- packaging layouts are not registered in the Unified Automated Information System (UAIS) of the SAUMD.
Therefore, in order to obtain the possibility of supplying APIs to the territory of Ukraine, it is necessary to register such substance, and to accompany the supply with a quality certificate in accordance with the requirements of the legislation.
The registration procedure starts from the moment of submitting the Application to the Ministry of Health of Ukraine. Thereafter, it is necessary to submit a registration form, pay the cost of expert evaluation and government levy, submit a registration dossier, and proceed with comments (if any). After API is recommended for registration at the meeting of the State Expert Center, drafts of the registration certificate, the QCM (quality control methods) and the labeling text are delivered to the Ministry of Health of Ukraine for inclusion in the draft and signing of the Order on Registration.
The time term of the specialized expert evaluation of the materials of the dossier of active substance is not more than 90 working days. However, this period does not include:
- the period of consideration of the Application and the registration form;
- payment of the state payments and receiving the payment confirmation;
- preliminary expert evaluation of the completeness of the registration dossier;
- the time required for the Applicant to respond to the observations;
- final actions after expert evaluation (checking/proofreading of drafts of the registration certificate and its addenda);
- period of signing the Order of the MOH on registration of the medicinal product.
The above actions take an average of 2 to 4 months and accordingly extend the final duration of the registration period.
During the registration procedure, the competent authorities may request missing documents or information at different stages. During the specialized expert evaluation, the deadline for responding to observations, or justifying the timing of their submission is 90 working days.
In the case when the Applicant does not provide the requested data or the provided data are not complete, the registration materials are withdrawn from consideration, and the amounts paid are not returned.
The registration certificate for API is issued for a period of 5 years, and after re-registration the certificate of unlimited duration is issued. The registration certificate consists of the certificate itself, as well as addenda to it: QCM (quality control methods) and labeling text.
Similarly to finished medicinal products, the registration certificate is issued in the name of the Applicant (Holder of the Registration) who can be a resident or non-resident of Ukraine.
Services and activities of “Cratia”:
For more than 12 years our company professionally performs the activities of registration of medicinal products in Ukraine, including active pharmaceutical ingredients (substances).
We offer the performance of activities on registration of APIs "on a turn-key basis", and also are ready to perform the following activities:
- patent search;
- checking the registration documentation for compliance with legislative requirements;
- translation of scientific, medical, technical and legal documentation;
- development of QCM (quality control methods) in accordance with the requirements of the legislation.