Arina Kostina participated in the seminar “Licensing of medicinal product import”
Junior associate of Legal Alliance Company Arina Kostina took part in the seminar “Licensing of medicinal product import. Practical aspects of development and implementation of pharmaceutical quality system of the importer according to the requirements of the GMP, GDP and GSP guidelines”, which was held on August 21, 2014. The event was organized by UkrMedCert Company.
The spokesperson was Nataliya Litvinenko, the Deputy Head of Manufacturing Licensing and Certification Administration - Head of Division of Manufacturing Licensing and Licensing Compliance of the State Service of Ukraine on Medicinal Products (SSUMP). In her presentation Ms. Litvinenko paid particular attention to practical aspects of application GMP requirements to medicinal product import, listed in the chapter III “Special requirements” of the License conditions for conducting commercial activities of medicinal products import, approved by the order of the Ministry of Health of Ukraine of 20.02.2013 No. 143, as revised by the order of the Ministry of Health of Ukraine of 08.11.2013 No. 960 (hereafter – Special requirements of Licensed conditions).
It should be reminded that there are three stages of implementation of the Special requirements of Licensed conditions, in particular:
During the first stage prior to December 01, 2013 the importers were to introduce master files of the importers, as well as to confirm compliance with the requirements set for personnel, premises and equipment, quality control, procedures of batch release, reclamation and recall.
The second stage shall be completed until December 01, 2014. It encompasses implementation of provisions concerning Documentation and Internal Audits (Self-Inspections) according to paragraphs 3.4 and 3.9 of the Special requirements of Licensed Conditions.
In this regard it should be mentioned that until December 01, 2014 the importers need to develop written procedure (methodic, SOP) relating management of documents and records. ISO 9001:2008 can serve as an example in this case. In order to comply with the requirements concerning internal audits (self-inspections) it is necessary to develop plan (scheme) of structural units indicating their level of involvement in the pharmaceutical quality system (fully, partially, not involved); train at least one person for conducting audits (internal inspectors must know legislative requirements to the importers, requirements set by GxP guidelines, as well as internal documentation of the importer in regard of the product quality); and develop procedure and annual plan of internal audits.
The third stage of implementation of the Special requirements of License Conditions envisages implementation by the importer until March 01, 2016 of “pharmaceutical quality system”, procedures of ongoing stability testing of medicinal products, external (outsourcing) activity, as well as control and retain samples storage. As of today these requirements are not obligatory.
Noteworthy, that the seminar provided with an opportunity to discuss other matters of concern of the importers, in particular: development of employment position instructions of the Authorized Persons, order of payment of state duties (to state treasury at the place of registration), passing inspections etc.