CABINET OF MINISTERS OF THE REPUBLIC OF AZERBAIJAN DECISION 2007 of the Cabinet of Ministers of the Republic of Azerbaijan on approving the “Rules for State Registration of Medicinal Products, Medicines and Medical Devices, Entering them in the State Register and Keeping the State Register” and “Rules for State Registration and Keeping the Register of Medicinal Products” on the cancellation of Decision No. 108 dated July 13
In accordance with the eighth paragraph of Article 119 of the Constitution of the Republic of Azerbaijan, the implementation of the Law of the Republic of Azerbaijan No. 979-VIQD dated July 14, 2023 on amending the Law of the Republic of Azerbaijan “On Medicines” and the implementation of the Law of the Republic of Azerbaijan “On Medicines” “On Amendments to Decree No. 528 of the President of the Republic of Azerbaijan dated February 6, 2007” In order to ensure the implementation of subsection 2.2.3 of Decree No. 2298 of the President of the Republic of Azerbaijan dated August 15, 2023, the Cabinet of Ministers of the Republic of Azerbaijan decides: 1. “Rules for state registration of drugs, medicinal substances and medical devices, inclusion in the state register and maintenance of the state register” should be approved (attached).
2. Resolution No. 108 of the Cabinet of Ministers of the Republic of Azerbaijan dated July 13, 2007 on the approval of the “Rules for State Registration and Registration of Medicines” (Legislative Collection of the Republic of Azerbaijan, 2007, No. 7, Article 735 (Vol. I)) be done. 3. This Decision can be amended in accordance with clause 3.5 of the “Regulation on the procedure for preparing, agreeing, adopting and publishing drafts of normative legal acts of executive authorities” approved by Decree No. 2328 of the President of the Republic of Azerbaijan dated October 6, 2023 .
Ali Asadov Prime Minister of the Republic of Azerbaijan Baku city, July 18, 2024 No. 345
By Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan dated July 18, 2024 has been confirmed.
Obtaining state registration of drugs, medicinal substances and medical devices, entering them into the state register and maintaining the state register
RULES
Содержание
1. General provisions
1.1. These Regulations are prepared based on the first sentence of Article 6.8 of the Law of the Republic of Azerbaijan “On Medicines” (hereinafter – the Law) and Article 1.0.8, second paragraph of Article 6.1, 6.5, 6.13, 6- Taking into account Articles 2.15, 6-2.17 and 6-2.19, the rules for state registration of medicinal products, medicinal substances and medical devices in the Republic of Azerbaijan, inclusion of medicinal products in the state register (hereinafter – the state register) and state registry determines.
1.2. According to Articles 1.0.8, 6.3, 6.6-1 and 9-1.6 of the Law, the following are registered: 1.2.1. medicines (original medicines, analogues of medicines (generics), new combinations of state-registered medicines, medicines whose state registration has expired, unpackaged medicines and medicines packaged for medical institutions);
1.2.2. medicinal substances;
1.3. Medicinal products, as well as medicinal substances, are examined taking into account the requirements of Clause 1.7 of these Regulations and the “Rule of conducting the examination of medicinal products, including simplified examination” approved by the Decision No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019 is held and according to the results of this examination, it is registered and entered into the state register.
1.2.3. medical devices with a higher, high and (or) medium risk level.
1.4. Medicinal products, medicinal substances and medical devices whose validity period of the registration card on the state registration of the medicinal product (hereinafter – the registration card) has expired are re-registered in the state, taking into account clauses 6.8 and 7.8 of these Regulations.
1.5. If any changes are made to the information contained in the documents specified in parts 3 and 4 of these Regulations required for the registration of state-registered drugs, medicinal substances and medical devices, those changes must be state-registered.
1.6. Taking into account Article 6.14 of the Law, drugs, medicinal substances and medical devices are registered by the Ministry of Health of the Republic of Azerbaijan (hereinafter – the Ministry) and entered into the state register, and their import into the territory of the Republic of Azerbaijan, production, sale and use in the territory of the Republic of Azerbaijan are allowed.
1.7. Manufactured in at least one of the countries listed in the “List of countries and foreign (international) organizations subject to recognition of foreign (international) registration of medicinal products” approved by Resolution No. 480 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 26, 2023, state registered and The procedure for the recognition of foreign (international) registration and state registry of medicinal products that have been approved for sale or have been approved for use by foreign (international) organizations, as well as manufactured in other countries and state registered in at least two of the countries on that list and allowed to be sold in these countries It is carried out in accordance with Article 6-2.
2. Basic concepts
2.1. The following concepts are used in these Rules:
2.1.1 applicant – according to Articles 6.1 and 9.5 of the Law, applying for the state registration (re-state registration) of drugs, medicinal substances and medical devices or the registration of changes made in the registration documents of drugs, medicinal substances and medical devices inventor, manufacturer, wholesale pharmaceutical enterprise or the Ministry of Health of the Republic of Azerbaijan, as well as a legal entity or an individual who is not a manufacturer or wholesale pharmaceutical enterprise of medicinal products applying for state registration (re-state registration) of medical devices or registration of changes made in registration documents entrepreneur;
2.1.2. global nomenclature of medical devices (hereinafter – TVQN) – the international system of codes and terms adopted for the purpose of identification of medical devices;
2.1.3. registration card number – a unique number assigned to a medicinal product, medicinal substance or medicinal product upon state registration;
2.1.4. components of medical devices – a device that is not a medical device or an accessory of a medical device, including blocks, parts, elements, materials, spare parts designed by the manufacturer of the medical device for use in the composition of the medical device or together with it.
2.2. Other concepts used in these Rules express the meanings provided by the Law and other normative legal acts of the Republic of Azerbaijan regulating the relations arising in this field.
3. Application for state registration (re-state registration) of medicinal products and medicinal substances and state registration of changes made in their registration documents
3.1. Application for state registration (re-state registration) of medicinal products and medicinal substances and state registration of changes made in their registration documents in accordance with Part 3 of these Regulations, by Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019 in accordance with the approved “Rule for conducting the examination of medicinal products, including simplified examination” by the “Analytical Expertise Center” public legal entity (hereinafter – the Institution) and the medicinal product and medicinal substance in the manner determined by Part 6 of these Rules includes the stages of issuing a registration card.
3.2. In order to receive state registration (re-state registration) of medicinal products and packaged medicinal products for medical institutions, the applicant submits the following to the Ministry along with the application specified in Appendix No. 1 of these Regulations: 3.2.1. In accordance with the “Rule for conducting the expertise of medicinal products, including simplified expertise” approved by the Resolution of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019 No. 502, the registration form of the medicinal product and registration documents in the required General Technical Document format (homeopathic medicinal products and and relevant registration forms for Active Pharmaceutical Ingredient);
3.2.2. if the applicant is a resident legal entity, a copy of the extract from the state register of legal entities, if the applicant is a foreign legal entity, a copy of the document confirming that it is registered in the country of its residence;
3.2.3. a copy of the applicant’s certificate of registration as a taxpayer;
3.2.4. if the applicant is an individual entrepreneur, a copy of the identity card;
3.2.5. 3 samples of the primary and (or) second packaging (in the case of a medicinal substance, samples in a volume sufficient to carry out the analysis of the medicinal substance three times);
3.2.6. instructions for use of the medicinal product and its notarized translation into Azerbaijani.
3.3. For the purpose of obtaining state registration (re-state registration) of an unpackaged medicinal product, the applicant shall submit the documents specified in subsections 3.2.1-3.2.6 of these Regulations together with the application to the Ministry, and the applicant shall submit the documents of these Regulations with the application to the Ministry for the purpose of obtaining state registration (re-state registration) of medicinal substances. Submits the documents specified in subsections 3.2.1-3.2.5.
3.4. In order to obtain state registration of the changes made in the registration documents of the medicinal product and medicinal substances, the applicant submits the following documents to the Ministry together with the application and those specified in subsections 3.2.1-3.2.6 of these Regulations:
3.4.1. the original of the registration card in case of changes in the information reflected in the registration card;
3.4.2. in case of changes to the content of the document provided for in subsection 3.2.6 of these Rules, an updated copy of that document.
3.5. When the documents specified in clauses 3.2-3.4 of these Rules are submitted by the applicant’s authorized person (representative), a document confirming his/her respective rights (power of attorney, contract, etc.) must be attached to the application.
3.6. When it is possible to obtain the documents or information that must be attached to the application by the Ministry in subsections 3.2.1-3.2.4, as well as in clauses 3.3 and 3.4 of these Regulations, those documents and or information is not requested from the applicant. In cases where it is not possible to obtain such documents or information through the Electronic Government Information System, their submission shall be requested from the relevant state body (institution) with the consent of the applicant or provided by the applicant.
4. Application for state registration (re-state registration) of a medical device and state registration of changes made in the registration documents of a medical device
4.1. State registration (re-state registration) of a medical device and state registration of changes made in the registration documents of a medical device Applying in the manner determined by Part 4 of these Rules, in accordance with Clause 4.4 of these Rules of the Cabinet of Ministers of the Republic of Azerbaijan dated 25.2019 In accordance with the “Rule for Conducting Expertise of Medicinal Products, including Simplified Expertise” approved by Resolution No. 502 of December 2018, it includes the stages of conducting the examination by the Institution and issuing the registration certificate to the medicinal product in the manner determined by Part 7 of these Rules.
4.2. Pursuant to Article 1.0.8 of the Law, in order to obtain state registration (re-state registration) of medical devices with a higher, high and (or) average risk level, the following shall be submitted by the applicant to the Ministry together with the application containing Appendix No. 1 of these Regulations:
4.2.1. a copy of the document confirming the production right of the manufacturer of the medical device and its annex;
4.2.2. A notarized copy of any of the following documents translated into Azerbaijani:
4.2.2.1. a document confirming the state registration of the medical device in the country where it is manufactured, and if it is not state registered in that country, the document (documents) confirming the state registration in another country (countries);
4.2.2.2. a certificate on free sale or export of a medical device (if any);
4.2.3. a brief description of the areas of application, purpose, and component of the medical device given by the manufacturer of the medical device;
4.2.4. information on the labeling and packaging of the medical device provided by the manufacturer of the medical device (color models of packaging and labels, content in Azerbaijani);
4.2.5. if the medicinal product provided by the manufacturer contains a medicinal substance, the composition and quantity of that medicinal substance, information on the compatibility of the medicinal substance with medicine;
4.2.6. biosafety information provided by the manufacturer;
4.2.7. a notarized copy of the document provided by the manufacturer, which contains information on the validation of testing methods and packaging, test results for containing microorganisms (bioload level), pyrogenicity and sterility, and process validation in relation to sterile medical devices, translated into Azerbaijani by a notary;
4.2.8. declaration of compliance with the safety and effectiveness requirements of the production of the medical device, indicating the risk level given by the manufacturer;
4.2.9. a copy of the certificate on the quality management system of the production of the medical device issued by the manufacturer;
4.2.10. Documents stipulated in Articles 18.2.1-18.2.3 of the Law of the Republic of Azerbaijan “On Licenses and Permits”;
4.2.11. a copy of the document issued by the manufacturer on the usability of medical devices (in relation to used medical devices).
4.3. Sub-paragraphs 4.2.1, 4.2.2, 4.2.8 and 4.2.9 of these Regulations are related to medical devices produced in the Republic of Azerbaijan, and sub-paragraph 4.2.5 provides information through examination of samples taken from the human body in a test tube. in relation to medical devices used for the purchase, and subsection 4.2.6 does not apply in relation to medical devices that are not in contact with the body of the person whose application is intended.
4.4. If there is information about the medicinal substance in the documents submitted during the state registration of the medicinal products prepared in a pharmaceutical form with a certain dose, consisting of natural, synthetic substances and their compounds, then an examination by the Institution must be carried out before state registration in order to determine the quality, effectiveness and safety of the medicinal substances contained in it. The implementation of this expertise is carried out according to the “Rule for conducting the expertise of medicinal products, including simplified expertise” approved by the Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019. 4.5. The documents or information that must be attached to the application in clauses 4.2 and 4.3 of these Rules by the institution are obtained in accordance with clause 3.6 of these Rules.
5. Grounds for refusal of state registration (re-state registration) of medicinal product, medicinal substance or medical device, changes made in their registration documents
5.1. State registration (re-state registration) of a drug, medicinal substance or medical device and state registration of changes made in the registration documents of a drug, medicinal substance or medical device are refused in the following cases:
5.1.1. if the documents specified in parts 3 and 4 of these Rules are not fully submitted and this deficiency is not eliminated in accordance with Article 52 of the Law of the Republic of Azerbaijan “On Administrative Proceedings”;
5.1.2. when untrue information is found in the submitted documents;
5.1.3. if the result of the expert opinion conducted by the Institution in relation to medicines and medicinal substances is negative;
5.1.4. in case of inconsistency in the submitted documents regarding the quality, effectiveness and safety of the medical device.
5.2. In the case of a decision to refuse the state registration (re-state registration) of drugs and medicinal products, as well as the state registration of medicinal substances and the changes made in their registration documents, the applicant must be informed about this within 2 (two) working days by registered mail.
6. Issuance of a registration card for a medicinal product and medicinal substance
6.1. Based on the results of reviewing the application and the documents attached to it, within 7 (seven) working days from the date of registration of the application, the Ministry shall inform the applicant of these Regulations for the purpose of state registration of medicinal products, including packaged medicinal products for medical institutions, or state registration of changes made to their registration documents. A registration card is issued in the form specified in the annexes 4A or 4B (in the case of medicinal products packaged for medical institutions, an appropriate note is made about this in the packaging information section of the registration card).
6.2. Based on the result of reviewing the application and the documents attached to it, within 7 (seven) business days from the date of registration of the application, for the purpose of state registration of unpackaged medicinal products or medicinal substances, or for state registration of changes made in their registration documents, the applicant shall be required to comply with 2A or 2B of these Regulations, respectively. , a registration card is issued in the form indicated in the annexes No. 3A or 3B.
6.3. If deficiencies are found in the application and the documents attached to it that can be eliminated and do not lead to the refusal of the registration card, the Ministry shall provide the applicant with information on their elimination or send it by registered mail no later than 5 (five) working days from the date of registration of the application and explains to him the legal consequences of non-compliance with formal requirements. All deficiencies are reported to the applicant at the same time.
6.4. The applicant must eliminate those deficiencies no later than 10 (ten) working days after receiving the information. At this time, the period for issuing a registration card is suspended, and the suspended period is not included in the period for issuing a registration card. After the applicant’s request to eliminate the deficiencies, the period is restored.
6.5. If the applicant does not eliminate the deficiencies found in the application and the documents attached to it within the period specified in clause 6.4 of these Regulations, the Ministry adopts an administrative act on keeping the application pending and provides the information about it to the applicant within 2 (two) working days or sends it by registered mail.
6.6. After eliminating the identified deficiencies, the applicant can apply to the Ministry with a repeated application for obtaining a registration card.
6.7. When applying for state registration of a medicinal product and medicinal substances included in its composition, separate registration certificates are issued for the medicinal product and the medicinal substance.
6.8. In order for the import to be uninterrupted, the applicant can apply to the Ministry at least 90 (ninety) calendar days before the expiration of the validity of the registration card for re-registration of the medicinal product or medicinal substance.
6.9. The date of the registration card for re-registration of the medicinal product or medicinal substance is considered to be the next day after the day when the previous registration card became invalid.
6.10. Each pharmaceutical form and dose of the active ingredient of a medicinal product containing the same medicinal substance in different pharmaceutical forms and (or) the dosage of the active ingredient is different is subject to state registration or re-registration. For this, a separate application is made and a registration card is issued for each pharmaceutical form and dosage of the active substance.
6.11. When the same medicinal product is produced by different manufacturers (responsible for all production processes), a separate expert opinion is required for each of them, and each medicinal product are separately registered or re-registered and a registration card is issued for each of them. In order to issue a registration card, a state fee is paid in accordance with the Law of the Republic of Azerbaijan “On State Fee”.
6.12. When there is any change in the information contained in the registration card, a new registration card is drawn up in accordance with Part 6 of these Regulations, keeping the registration number, and the date of the change is recorded in the registration card. From the date of submission of the expert opinion to the Ministry, the applicant is issued a registration card in the form specified in Appendix No. 3B, 4B and 5 of these Regulations within 7 (seven) working days. At this time, a payment is required in accordance with the Law of the Republic of Azerbaijan “On State Fee” for issuing a registration card. The date of state registration of the change is indicated in the new registration card. In such cases, the validity period of the new registration card is limited to the period of the previous registration card.
6.13. In case of changes in the registration documents that are not related to the information contained in the registration card, the changes are registered in the state according to the procedure established by Part 6 of these Regulations without drawing up a new registration card.
6.14. If the registration card is lost or damaged, a duplicate card is issued based on the applicant’s request, and an appropriate note is made on the duplicate card that the card is a duplicate. In this case, no state fee is required for issuing a registration card. The damaged registration card must be submitted to the Ministry.
6.15. The period of consideration of the applicant’s application for obtaining a registration card does not include the periods of expertise of medicinal products and medicinal substances determined by the Law.
6.16. For state registration (re-state registration) of a medicinal product, medicinal substance or medicinal product, for state registration of changes made in their registration documents, the applicant shall, according to Articles 1-1 and 6.10 of the Law, 5 (five) days after receiving the notification by the Institution must pay the state fee in accordance with the Law of the Republic of Azerbaijan “On State Fee” within 10 days.
7. Issuance of a medical device registration card
7.1. If there are no deficiencies in the submitted documents, within 7 (seven) working days from the date of submission of those documents to the Ministry by the applicant, and in relation to the medical devices specified in clause 4.4 of these Regulations, within 7 (seven) working days from the date of submission of the expert opinion to the Ministry according to No. 5 of these Regulations The registration certificate is issued by the Ministry in the form specified in the appendix.
7.2. When there is any change in the information contained in the registration card, a new registration card is drawn up, keeping the registration number. A registration card in the form specified in Appendix No. 6 of these Regulations is issued to the applicant within 7 (seven) working days from the day of application to the Ministry by the applicant, and within 7 (seven) working days from the day of submission of the expert opinion to the Ministry in relation to the medical devices specified in clause 4.4 of these Regulations. The new registration card also shows the date of state registration of the change. The validity period of the new registration card is limited to the validity period of the previous registration card.
7.3. If deficiencies are found in the application and the documents attached to it that can be eliminated and do not lead to the refusal of the registration card, the Ministry shall provide the applicant with information on their elimination or send it by registered mail no later than 5 (five) working days from the date of registration of the application and explains to him the legal consequences of non-compliance with formal requirements. All deficiencies are reported to the applicant at the same time.
7.4. The applicant must eliminate these deficiencies within 10 (ten) working days at the latest from the time of receiving the information. At this time, the period for issuing a registration card is suspended, and the suspended period is not included in the period for issuing a registration card. After the applicant’s request to eliminate the deficiencies, the period is restored.
7.5. If the applicant does not eliminate the deficiencies found in the application and the documents attached to it within the period specified in clause 7.4 of these Regulations, the Ministry adopts an administrative act on keeping the application pending and provides information about it to the applicant within 2 (two) working days or by registered mail. sends.
7.6. After eliminating the identified deficiencies, the applicant can apply to the Ministry with a repeated application for obtaining a registration card.
7.7. If amendments are made to the information contained in the registration card in Appendices No. 5 and 6 of these Regulations that do not lead to a change, the change is entered into state registration without drawing up a new registration card.
7.8. The applicant can apply to the Ministry at least 7 (seven) working days before the expiration of the registration card for the purpose of re-registration of the medical device. The holder of the license must apply to the Ministry within 7 (seven) working days for the state registration of the changes made in the registration documents of medical devices.
7.9. The date of entry into force of the certificate of re-registration of the medical device is considered to be the next day after the expiry of the previous registration certificate.
7.10. Components included in the composition of medical devices and not used independently are registered as a set through that medicine.
7.11. If the registration card issued to the medical device is lost or damaged, the provisions of clause 6.14 of these Rules shall be applied.
7.12. The period of consideration of the applicant’s application for obtaining the registration card issued to the medical device does not include the periods of examination of medicinal substances specified by the Law specified in clause 4.4 of these Regulations.
8. Validity period of the registration card
8.1. The registration certificate issued to a medicinal product, medicinal substance and medicinal product is valid for a period of 5 (five) years.
9. Approval of instructions for use of drugs and medical devices during registration, state re-registration and changes in registration documents
9.1. The notarized translation of the medicinal product and the instructions for use of the medicinal product containing the medicinal substance in the Azerbaijani language is submitted by the applicant, checked by the Institution and approved by the Ministry.
9.2. The approved instructions for use of the state-registered drugs and medical devices in the Republic of Azerbaijan are posted on the official website of the Institution (in PDF format).
10. Keeping the state register of state-registered drugs, drug substances and medical devices
10.1. The state register of state-registered medicinal products, medicinal substances and medicinal products is carried out by the Ministry through the Institution.
10.2. In relation to state-registered medicinal products, the information specified in Article 6-2.15 of the Law is entered into the state register. Also, the name of the trademark written in the Azerbaijani language on the registration card is recorded in the register.
10.3. In relation to medicinal substances, the state register is referred to in Articles 6-2.15.2, 6-2.15.4-6-2.15.6, 6-2.15.9-6.2.15.14 of the Law and the Law of the Republic of Azerbaijan “On Licenses and Permits” The information mentioned in Article 8 is posted.
10.4. In relation to medical devices, the following information is included in the state register:
10.4.1. the trademark name of the medicinal product;
10.4.2. type of medical device;
10.4.3. degree of risk;
10.4.4. description of primary and (or) secondary packaging;
10.4.5. assemblers;
10.4.6. TVQN code;
10.4.7. information about the active substance and dosage of the medicinal substance if the medicinal product contains a medicinal substance.
10.5. Registration card, description of primary or secondary packaging, instructions for use are uploaded to the state register in electronic format.
10.6. When the state registration of medicinal products, medicinal substances and medical devices is canceled, information about the cancellation of their state registration and the date of cancellation are recorded in the state register. When the validity period of the state registration of medicinal products expires, records are made in the state register in accordance with Article 6.12 of the Law, indicating the expiration date of their state registration. When the state registration is suspended in accordance with the grounds defined by Part 11 of these Rules, the date of suspension and suspension of their state registration is recorded in the state register.
10.7. The information entered into the state register is compiled in electronic form and posted on the official website of the Ministry and the Institution.
11. Grounds for suspension of state registration of drugs, medicinal substances and medical devices
11.1. In addition to the cases provided for in Article 25 of the Law of the Republic of Azerbaijan “On Licenses and Permits”, their state registration is suspended by the Ministry if one of the following cases is determined in relation to state-registered drugs, medicinal substances and medical devices:
11.1.1. in the case of side effects that are not specified in the instructions for use of the medicinal product, despite its application in accordance with the instructions for use; 11.1.2. Lack of therapeutic effectiveness of the medicinal product and medicinal substance as a result of the evaluation of the benefit/risk ratio according to the “Pharmacocontrol Regulation of Medicines” (hereinafter – the “Pharmacocontrol Regulation of Medicines”) approved by the Decision No. 503 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019 or when found to be insufficient;
11.1.3. if the packaging and marking requirements are not followed and the official warning given by the Institution to the license holder is not taken into account;
11.1.4. According to Article 4.3-1 of the Law, when justified facts about the lack of quality, effectiveness and safety of the state-registered medicinal product are discovered by the Ministry and a corresponding decision is made to prohibit its use in the Republic of Azerbaijan.
11.2. Import of drugs, medicinal substances and medical devices whose state registration has been suspended into the Republic of Azerbaijan, production and sale for sale in the territory of the Republic of Azerbaijan and discontinued. Taking into account the reason for the suspension of state registration, the decision on the recall of drugs, medicinal substances and medical devices in circulation by the Ministry is based on the “Rule of recall of drugs” approved by the Resolution of the Cabinet of Ministers of the Republic of Azerbaijan dated November 27, 2019 No. 460 is given.
11.3. In the case of suspension of state registration, when a corresponding decision is made by the Ministry, written information is immediately sent to the license holder.
11.4. The state registration of medicinal products, medicinal substances, and medicinal products is suspended until the circumstances specified by Clause 11.1 of these Regulations are eliminated, and information about this is published in the press in accordance with Article 16 of the Law.
12. Grounds for cancellation of state registration of drugs, medicinal substances and medical devices
12.1. In addition to the cases mentioned in Article 26.1 of the Law of the Republic of Azerbaijan “On Licenses and Permits”, the state registration of drugs, medicinal substances and medical devices is canceled in the following cases:
12.1.1. When the duties of the license holder in the field of pharmacocontrol implementation defined by the “Pharmacocontrol Regulation of Medicinal Products” are violated by the holder of the registration card;
12.1.2. If the evaluation of the benefit/risk ratio according to the requirements of the “Pharmacocontrol Regulation of Medicinal Products” results negatively;
12.1.3 when the Institution gives a final opinion on the non-compliance of the medicinal product and medicinal substance with the requirements of the Reliable Manufacturing Practice during the inspection of the production area in accordance with the Law of the Republic of Azerbaijan “On the Regulation of Inspections Conducted in the Field of Entrepreneurship and Protection of the Interests of Entrepreneurs”;
12.1.4. Taking into account Article 4.3-1 of the Law, when inconsistency is found in the quality indicators of the three series of state-registered medicinal products, medicinal substances and medical products;
12.1.5. when the registered medicinal product, medicinal substance and medicinal product are produced in a composition different from the composition specified in the registration documents;
12.2. State registration of drugs, medicinal substances and medical devices is canceled by the decision of the Ministry with reference to the cases specified in clause 12.1 of these Rules. That decision is submitted to the owner of the registration card within 2 (two) working days from the date of its adoption or sent by registered mail.
12.3. Cancellation of state registration of medicinal products, medicinal substances and medicinal products is announced in the periodical press.
13. Confidentiality of Information
13.1. For the purposes of state registration and re-state registration, the Ministry and the Institution shall also ensure the confidentiality of the information provided during the state registration of the changes made in the registration documents. In order to ensure confidentiality, these data may not be disclosed to outsiders and may not be used for commercial purposes, taking into account the requirements of the laws of the Republic of Azerbaijan “On Information, Informatization and Information Protection”, “On Obtaining Information” and “On Commercial Secrets”.