General information

Опубліковано 13.03.2019 о 14:13

The Department of Licensing of manufacture, Import of Medicines, Monitoring of Compliance with Licensing Conditions and Certification informs applicants about obtaining administrative services for the quarantine period:

 

In order to obtain licenses for the right to conduct business activities for the production, import of medicines (except for active pharmaceutical ingredients), wholesale and retail trade, applicants can submit documents through the website    https://e-services.dls.gov.ua and further track applications online or send documents by mail with a description of the attachment.

 

In order to obtain conclusions and certificates of conformity of the conditions of production of medicinal products to the requirements of good manufacturing practice, certificates of medicinal products, confirmation for active pharmaceutical ingredients exported to the European Union (EU) for medicinal products intended for human consumption, applicants may send documents by post (without description of the attachment) or submit them to the mailbox of the State  Service. In addition, correspondence is carried out on a regular basis via the official e-mail address (dls@dls.gov.ua).

 

Issuance of documents is carried out in compliance with the conditions of quarantine, in personal protective equipment, both by an employee of the State Service and a representative of the business entity.

 

Management of licensing of manufacture, import of medicines, control over observance of licensing conditions and certification

 

Department of licensing of manufacture of medicines and control over observance of license conditions:

 

licensing of economic activity for the production of medicines and import of medicines (except for active pharmaceutical ingredients) (issuance, renewal and revocation of licenses, extension and narrowing of licenses, amendments), ensuring the organization and conduct of inspections before the issuance of licenses or the opening of new places of business, expanding the production of dosage forms, expanding activities.

ensuring the organization and conduct of inspections of manufacturers of medicines and importers for compliance with the licensing conditions of business activities for the production of medicines and imports of medicines (except for active pharmaceutical ingredients).

 

Manufacture certification department

 

carrying out activities to confirm the compliance of the conditions of production of medicinal products with the requirements of good manufacturing practice.

ensuring the organization and conduct of inspections of the production of medicines for compliance with the requirements of good manufacturing practice (including inspection of foreign industries).

certification of quality of medicines for international trade and confirmation for exported active pharmaceutical ingredients.

 

Legislation of Ukraine on the above mentioned issues:

 

1. Law of Ukraine «On Medicines»

https://www.zakon3.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80

 

2. Law of Ukraine «The Fundamentals of Legislation on Health Care»

https://www.zakon5.rada.gov.ua/laws/show/2801-12

 

3. Law of Ukraine «Licensing of Different Types of Economic Activities»

https://www.zakon5.rada.gov.ua/laws/show/222-19

 

4. Law of Ukraine «Basic Principles of State Supervision (Control) of Economic Activities»

https://www.zakon3.rada.gov.ua/laws/show/877-16

 

5. Resolution of the Cabinet of Ministers of Ukraine of August 5, 2015 No. 609 «On Approval of the List of the state licensing authorities and Recognition of some invalid Decisions of the Cabinet of Ministers of Ukraine»

https://zakon.rada.gov.ua/laws/show/609-2015-%D0%BF?lang=en

 

6. Resolution of the Cabinet of Ministers of Ukraine of September 10, 2008 No. 843 «On Approval of the Criterion for Assessing the Risk of Activities in the Health Care for the Safety of Life and Health of the Population and Determining the Periodicity of Implementation of Planned Measures of State Supervision (Control)»

https://zakon.rada.gov.ua/laws/show/843-2008-%D0%BF?lang=en

 

7. Resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929 «On approval of Licensing conditions for conducting economic activities for the production of medicinal products, wholesale and retail trade in medicinal products, import of medicines (except for active pharmaceutical ingredients)»

https://zakon.rada.gov.ua/laws/show/929-2016-%D0%BF/paran12?lang=en

 

8. Order of the Ministry of Health of Ukraine of December 27, 2012 No. 1130 «Procedure for conducting confirmation of conformity of manufacturing conditions with good manufacturing practice requirements», registered by the Ministry of Justice of Ukraine on January 21, 2013 No.133/22665

https://zakon.rada.gov.ua/laws/show/z0133-13/ed20121227?lang=en

 

9. Order of the Ministry of Health of Ukraine of December 07, 2012 No.1008 «On Approval of the Procedure for Quality Certification of Medicinal Products for International Trade and Validation for Active Pharmaceutical Ingredients Exported»

https://zakon.rada.gov.ua/laws/show/z2218-12?lang=en

 

10. Guidelines ST-N MOH 42 4.0: 2020 “Medicines. Good manufacturing practice »

 

11. 42-01:2003 «Guideline. Medicines. Technological process. Documentation»

https://zakon.rada.gov.ua/rada/show/v0107282-03/sp:max100?sp=:max100&lang=en

 

12. ST-N МОHU 42-4.1:2011 «Guideline. Dossier of manufacturing site»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%94%D0%BE%D1%81%D1%8C%D0%B5-%D0%92%D0%94.pdf

 

13. ST-N МОHU 42-3.0:2011 «Guideline. Pharmaceutical Development»

 

14. ST-N МОHU 42-4.2:2011 «Guideline. Risk Management for Quality»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%A3%D0%BF%D1%80%D0%B0%D0%B2%D0%BB%D1%96%D0%BD%D0%BD%D1%8F-%D1%80%D0%B8%D0%B7%D0%B8%D0%BA%D0%B0%D0%BC%D0%B8-ICH-Q9.pdf

 

15. ST-N МОHU 42-4.3:2011 «Guideline. Pharmaceutical Quality System»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%A4%D0%B0%D1%80%D0%BC%D0%B0%D1%86%D0%B5%D0%B2%D1%82%D0%B8%D1%87%D0%BD%D0%B0-%D1%81%D0%B8%D1%81%D1%82%D0%B5%D0%BC%D0%B0-%D1%8F%D0%BA%D0%BE%D1%81%D1%82%D1%96.pdf

 

16. ST-N МОHU 42-4.4:2011 «Guideline. International Harmonized Certification Requirements Series»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%9C%D1%96%D0%B6%D0%BD%D0%B0%D1%80%D0%BE%D0%B4%D0%BD%D1%96.pdf

 

17. ST-N МОHU 42-5.1:2011 «Guideline. Good storage practice»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97%D0%9D%D0%9F%D0%97.pdf

 

18. ST-N МОHU 42-4.5:2012 «Guideline. Good practice of cultivating and harvesting raw materials of plant origin»

https://zakon.rada.gov.ua/rada/show/v0118282-13?lang=en

 

19. ST-N МОHU 42-3.7:2013 «Guideline. Quality of water for use in pharmacy»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%AF%D0%BA%D1%96%D1%81%D1%82%D1%8C-%D0%B2%D0%BE%D0%B4%D0%B8.pdf

 

20. ST-N МОHU 42-3.8:2013 «Guideline. Medicines. Pharmaceutical quality of medicines for inhalation and nasal preparations»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%A4%D0%B0%D1%80%D0%BC%D1%8F%D0%BA%D1%96%D1%81%D1%82%D1%8C.pdf

 

21. ST-N МОHU 42-4.6:2016 «Medicines. Some provisions regarding active substances exported to Ukraine for the manufacture of medicinal products»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%94%D0%B5%D1%8F%D0%BA%D1%96-%D0%BF%D0%BE%D0%BB%D0%BE%D0%B6%D0%B5%D0%BD%D0%BD%D1%8F.pdf

 

22. ST-N МОHU 42-4.7:2016 «Medicines. Establishing the boundaries of health effects for use in identifying risk in the case of the production of various medicinal products through technical means of general use»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%9C%D0%B5%D0%B6%D1%96-%D0%B2%D0%BF%D0%BB%D0%B8%D0%B2%D1%83.pdf

 

23. ST-N МОHU 42-4.8:2016 «Medicines. Formalized general risk assessment to establish appropriate manufacturing practices for auxiliary substances used in human medicines»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%9E%D1%86%D1%96%D0%BD%D1%8E%D0%B2%D0%B0%D0%BD%D0%BD%D1%8F-%D1%80%D0%B8%D0%B7%D0%B8%D0%BA%D1%96%D0%B2.pdf

 

24. ST-N МОHU 42-3.5:2016 «Medicines. Validation of processes»

https://www.dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%92%D0%B0%D0%BB%D1%96%D0%B4%D0%B0%D1%86%D1%96%D1%8F-%D0%BF%D1%80%D0%BE%D1%86%D0%B5%D1%81%D1%96%D0%B2.pdf

 

25. ST-N MOHU 42-5.2: 2020 “Medicines. Principles of good practice for the distribution of active substances for human medicines “

26.  ST-N MOHU 42-3.4: 2020 ” Medicines. Guidelines for the production of finished medicines “

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