Regulator

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Regulatory Activities:

We provide services, which help companies with the promotion and escort of production to the market of Ukraine, such as:

  • Medicinal and immunobiological agents registration;
  • Makeup preparations and food additives certification;
  • National conformity assessment of medical devices according to the Technical Regulations;
  • Assessment of medicines manufacturing compliance with the Good Manufacturing Practice in Ukraine;
  • Pharmacovigilance and safety monitoring.

Registration of medicinal and immunobiological agents.

Pharmaceuticals registration is a complex process that requires heavy financial and time expenditures. A number of legislative and standart acts regulate the registration procedure of medicinal agents. Moreover, the Ukraine`s European integration track determines the introduction of fairly frequent and significant changes in this base for the purpose of our legislation unification to the European regulatory system. On the territory of Ukraine, only registered pharmaceuticals are allowed to realization (Cabinet of Ministers of Ukraine Regulation No. 376 of 26.05.2005). Ethical products fabricated in pharmacies or customized by treatment and preventive care establishments are exceptions. The state registration of medicinal agents is submitted to the Ministry of Health of Ukraine. In Ukraine, legislative requirements change quite often therefore we inform our partners about any serious innovation. To entrust professionals with the pharmaceuticals registration is your optimal decision.

Makeup preparations and food additives certification.

For the cosmetics importation and realization, an obligatory condition is the presence of a sanitary-and-epidemiologic statement (SES (The sanitary and epidemiological service) statement), which confirms the quality and safety of the products, defines the realization field and establishes the safety criterion. These certificates are issued by the authorized expert organizations of the Sanitary and Epidemiological Service of the Ministry of Health of Ukraine. The procedure consists of two main stages: the information dossier review about the cosmetic product and the laboratory analysis of finished product example. Contravention of these requirements carries a penalty of imprisonment for a term of 5 years.

Dietary supplements (biologically active additives) import and realization.

Importation and circulation of food products is regulated by the Law of Ukraine on quality and safety of food products and food raw meterials. When imported, the product must be escorted with an international certificate or other document issued by the competent authority of the country of origin. There are also certain requirements for the labeling of dietary supplements. While labeling, it is necessary to take into consideration the requirements of a number of legislative acts and also to monitor the regulatory requirements for relevance, with the view of labeling timely adaptation. The company Pharmasoft offers operative and professional assistance in acquisition of biologically active additives documentation.

National conformity assessment of medical devices according to the Technical Regulations

Since July 1, 2015, legislative requirements for permissive documentation have changed. This documentation has to escort medical products for their introduction to the market of Ukraine: there was a transition from the system of state registration of medical devices to the conformity assessment according to the Technical Regulations approved by Regulation of the Cabinet of Ministers of Ukraine No. 753, No. 754 , No. 755 of 02/10/2013.

Registered medical items are permitted for the introduction without national conformity assessment procedure before the expiry date of the certificate, but no later than July 1, 2017 (depending on what comes first).

For all medical items, equipments which have been introduced for the first time since July 1, 2015, it is necessary to pass national conformity assessment according to the Technical Regulations (Regulation of Cabinet of Ministers of Ukraine No. 753, No. 754, No. 755 of 02.10.2013).

The conformity assessment procedure according to the Technical Regulations is carried out in different ways depending on the category of the medical item, and gives the opportunity to choose the amount of expertises.

The mandatory requirement of the Technical Regulations for all categories of products, and for all types of conformity assessment procedures is the appointment of an authorized producer representative in Ukraine, in case when the producer himself is not a resident of Ukraine. We provide services in conducting national conformity assessment according to the Technical Regulations in Ukraine. We will undertake the process organization, form a set of documents and assist in carrying out the procedure in a short time.

Assessment of medicines manufacturing compliance with the Good Manufacturing Practice in Ukraine.

There is a document which currently regulates the assessment of medicines manufacturing compliance with the Good Manufacturing Practice:

Decree of the Ministry of Health of Ukraine on December 27, 2012 № 1130 On approving the verification procedure for medicinal product manufacturing compliance with the Good Manufacturing Practice requirements, registered in the Ministry of Justice of Ukraine 21 December 2013 p. For No. 133/22665 With changes introduced according to the Decree of the Ministry of Health Care Order

No. 452 dated July 22, 2015

№ 1197 dated 09.11.2016

The certificate of manufacturing compliance of production issued by the representative authority of the member-country PIC / S is the official document, which confirms medicinal product manufacturing compliance with the Good Manufacturing Practice. Conclusion based on this certificate or license of the manufacture of medicinal products in a case when the authorized body of the PIC / S member country does not provide the delivery of the certificate of medicinal product manufacturing compliance with the GMP. Such document is issued by the authorized body – the State Forestry Service of Ukraine, which is evidence of conformity of production to the requirements of good manufacturing practice. The Ukrainian GMP certificate is issued for a period of validity of the production license, but no more than 3 years.

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Pharmacovigilance and safety monitoring.

The manufacturer in accordance with international standards and current legislation of Ukraine must ensure the collection, analysis, processing and dissemination of information on the occurrence of adverse side effects associated with the use of its products on the territory of Ukraine
Timely emergence of adverse events is the key to the safety of medicines. This makes it possible to constantly assess the balance in which the benefits of using medicines exceed possible risks, and also develop and implement measures aimed at preventing the adverse effects of drug therapy, increasing its safety.
The legislative foundation in Ukraine for pharmacovigilance is:

The order of the pharmacological execution, asserted by the Ministry of Health of Ukraine on 27th of June 2006 No. 898, registrated in the Ministry of Justice of Ukraine on the 19th of December 2016 № 1649/29779 (the Ministry of Health of Ukraine dated 26 September 2016 року № 996).

We will provide pharmacovigilance in Ukraine for your medicines, such as:

  • Collecting and processing of spontaneous messages;
  • Maintaining of the database;
  • Maintaining of information delivery to authorized bodies;
  • Periodic reporting;
  • Screening of literary sources;
  • Staff training.