We would like to inform you about significant changes in registration and quality management of medicinal products in Ukraine.
1. Changes in the procedure for GMP recognition and certification.
On July 21, 2020, amendments to the Order of the Ministry of Health of Ukraine of December 27, 2012 No.1130 «On approval of the Procedure for confirming compliance of manufacturing conditions with good manufacturing practice requirements», approved by the Order of the Ministry of Health of Ukraine of 09.06.2020 No.1346, came into force.
The most important:
1) The list of countries for which the procedure for recognition of the Certificate of GMP Compliance is carried out has been changed. The recognition procedure applies only to certificates issued by the competent authorities of the EU Member States, Great Britain or countries which possess a mutual recognition agreement with the EU or Ukraine. Currently there are 35 countries:
- 27 EU countries: Austria, Belgium, Bulgaria, Greece, Denmark, Estonia, Ireland, Spain, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Germany, Poland, Portugal, Romania, Slovakia, Slovenia, Hungary, Finland, France, Croatia, Czech Republic, Sweden;
- Great Britain;
- countries which possess a mutual recognition agreement (MRA) with the EU: USA, Canada, Switzerland, New Zealand, Australia, Japan;
- сountries which possess an Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) with the EU: Israel.
Certificates оf GMP Compliance issued by regulatory authorities of other countries are not subject to the recognition procedure. We should remind that the recognition procedure was previously applicable for certificates issued by the competent authorities of the member countries of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
Thus, the recognition procedure becomes impossible for certificates issued by the competent authorities of Argentina, Hong Kong, Indonesia, Iran, Iceland, Korea, Liechtenstein, Malaysia, Mexico, Norway, South Africa, Singapore, Taiwan, Thailand and Turkey. GMP certificates issued by the competent authorities of these countries will require a production inspection procedure in Ukraine.
2) If at least one manufacturing stage is not carried out in the countries to which the recognition procedure is applied, a copy of the registration (authorization) from one of the 35 countries mentioned above must be submitted with the set of documents to the GMP Application. In the absence of registration (authorization), the manufacture of these medicinal products must be inspected for compliance with GMP requirements.
Copies of registration certificates (marketing authorization) are not subject to submission for manufacturers located in EU27, Great Britain or countries which possess a mutual recognition agreement with the EU or Ukraine.
The Procedure provides conducting remote assessment (remote inspection) of GMP conformity by the State Service of Ukraine on Medicines and Drugs Control (hereinafter – SMDC). The remote assessment can be conducted in case when Ukraine or any other country-manufacturer declares emergency, martial law, in case of natural disaster, when a disease is declared by the WHO as a pandemic and global healthcare emergency that makes impossible conduct of inspections including sanitary-epidemiological situation that increases risks for inspector (including risks for inspector’s life and health or any other reasons).
While conducting remote assessment video communication with the manufacturer of medicinal products may be applied to assess the production site/laboratory/warehouses, manufacturing documentation and quality system documentation on compliance with GMP requirements. Based on the results of the remote assessment, the report shall be prepared and a decision on GMP certificate issuance shall be made.
4) The SMDC may involve enterprises, institutions, organizations, and individual scientists and specialists for laboratory analysis of the quality of medicinal products samples, examinations, inspections, performance of certain types of work, etc.
5) The Applications submitted for confirmation of compliance of medicinal products manufacturing conditions with the GMP requirements registered prior to 21.07.2020 will be considered by the SMDC according to the previous version of the Order No. 1130.
2. Changes in the procedure for recognition of compliance of manufacturing conditions with the GMP requirements and certification.
On July 6, 2020, the SMDC announced that in order to optimize the process of evaluation of Applications and documents submitted for issuing a certificate or expert opinion on confirming compliance of manufacturing conditions with GMP requirements, state enterprises are involved:
- SE “Ukrainian Pharmaceutical Quality Institute”,
- SE “The Central Laboratory for Quality Analysis of Medicines and Medical Products”.
It is noted that GMP inspectors of state enterprises are included in the SMDC’s Register of GMP inspectors and their qualification is confirmed in accordance with the requirements of the SMDC quality system. SE “Ukrainian Pharmaceutical Institute of Quality”, SE “Central Laboratory for Quality Analysis of Medicines and Medical Products” in accordance with the Procedure and documents of the SMDC quality system have common approaches to the evaluation of applications on confirming compliance of manufacturing conditions with GMP requirements.
Сonsequently, Applicants (MAH’s) or their representatives submitting the documents for recognition of the GMP certificate must enter into an Agreement with an expert state enterprise and pay the cost of the work (approximately €100-150).
3. Changes in the registration procedure by verification of the authenticity.
On July 17, 2020, to substitute the Order of the Ministry of Health No. 721, The Order of 15.06.2020 No. 1391 was adopted, which approved the Procedure for verification of registration materials for their authenticity on a medicinal product submitted for state registration to be purchase by a person authorized to carry out healthcare procurement or a specialized organization.
The new Procedure applies to the registration of medicinal products purchased by (1) international specialized procurement organizations and (2) a person authorized to carry out healthcare procurement (SE “Medical Procurements of Ukraine”).
The procedure is carried out within 9 working days, however, the time required for preliminary financial and administrative actions and approval of the draft registration certificate is not included in the inspection period, as well as the time of approval of state registration by the order of the Ministry of Health.
1) The registration procedure by verification of the authenticity for medicinal products purchased by international specialized procurement organizations is close to the Order of the Ministry of Health No. 721.
For the purpose of registration the following documents are submitted in the Ministry of Health of Ukraine:
- Application for registration.
- Registration dossier materials that have been submitted to the reference competent authority or for WHO prequalification.
- Report on the assessment of the medicinal product.
- Methods of quality control of the medicinal product.
- Instructions for use, summary of the medicinal product characteristics (SmPC) of the reference country.
- Sample of the original packaging of the medicinal product.
- Translation of the packaging labeling text and instructions for use into Ukrainian.
We remind that variations (changes) since the initial registration that have been approved by the reference competent authority should also be included in the registration dossier.
The Application for registration must also contain the details of the contact person in Ukraine for pharmacovigilance. For registration of products purchased by international specialized procurement organizations, it is not required to submit a certificate or decision of the SMDC on confirmation of compliance with GMP requirements.
2) The registration procedure by verification of the authenticity for medicinal products purchased by SE “Medical Procurements of Ukraine” provides that a medicinal product is registered by the competent authority of the USA, Switzerland, Japan, Australia, Canada or the European Union under the centralized procedure and is applied in the territory of the reference country.
For the purpose of registration the following documents are submitted in the Ministry of Health of Ukraine:
- Application for registration.
- Registration dossier materials that have been submitted to the reference competent authority of the USA, Switzerland, Japan, Australia, Canada or the European Union under the centralized procedure.
- Report on the assessment of the medicinal product.
- Methods of quality control of a medicinal product.
- Instructions for use, summary of the medicinal product characteristics (SmPC) of the reference country.
- A sample of the original packaging of a medicinal product.
- Translation of the packaging labeling text, instructions for use and summary of the medicinal product characteristics into Ukrainian.
- Copy of the certificate or expert opinion on recognition of compliance of manufacturing conditions with GMP requirements issued by the SMDC or written commitment of the manufacturer to manufacture the respective medicinal product to supply in Ukraine at the same production facilities that are used in production for the reference country market.
The Application for registration must also contain the details of the contact person in Ukraine for pharmacovigilance.
4. Changes in the registration procedure under the simplified and abridged procedure.
On July 17, 2020, amendments to the Order of the Ministry of Health No. 1245 came into force, which approved the registration under the simplified and abridged procedure for medicinal products registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada or the European Union under the centralized procedure.
The registration procedure is supplemented by the requirement that the medicinal product must not only be registered with the US FDA, Swissmedic, PMDA, TGA, Health Canada or the European Medicines Agency, but must also must be used in the territory of the reference country or the European Union Member States.
For the purpose of registration the following documents are submitted to the Ministry of Health of Ukraine:
- Application for registration.
- Registration dossier materials that have been submitted to the reference competent authority with all variations approved after registration of such medicinal product.
- Materials regarding methods of quality control of a medicinal product in the Ukrainian language.
- Samples and text of package labeling.
- Instructions for use, summary of the medicinal product characteristics.
- Copy of the certificate or expert opinion on recognition of compliance of manufacturing conditions with GMP requirements issued by the SMDC or written commitment of the manufacturer to manufacture the respective medicinal product to supply in Ukraine at the same production facilities that are used in production for the reference country market.
- Specific cover and guarantee letters.
The Application for registration must also contain the details of the contact person in Ukraine for pharmacovigilance.
We remind that the timeline for the specialized assessment of the registration materials under this procedure is not more than 10 working days. This term does not include the time required to conclude the Agreement (14 days) and provide invoices (7 days), to make a single request for explanations or additional data (30 days), to approve the draft of the registration certificate, quality control methods, labeling text and instructions for use of a medicinal product, as well as to approve the state registration by the order of the Ministry of Health.
5. SI measurement units on the labeling
We remind that on January 1, 2021, the transition period ends, after which the measurement units on the labeling of products put into circulation must be performed using the International System of Units SI. The requirements of the Order of the Ministry of Economic Development of 04.08.2015 No. 914 apply to all products that are put into circulation in Ukraine including:
- medicinal products;
- medical devices;
- food products;
- cosmetics.
To implement SI measurement units in the labeling of medicinal products already registered in Ukraine, it is necessary to submit an Application for the appropriate type of variations to the Ministry of Health of Ukraine, undergo examination and approval by order of the Ministry of Health, obtain updated labeling text and submit color graphics layouts for registration with the EAIS of SMDC. We recommend starting the process immediately, as the procedure of state examination and approval of changes takes several calendar months.
Have any questions or want to know more? Contact us:
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info@cratia.ua