Since 1 March 2013 it became mandatory to obtain an Import License for all importing companies of medicinal products. These requirements are set by the Law of Ukraine “On Amending Certain Laws of Ukraine on Import Licensing of Medicinal Products and the Definition of an Active Pharmaceutical Ingredient” dated 4 July 2012. The import licensing terms are approved by Order of the Ministry of Health of Ukraine No.143 dated 20 February 2013 “On Approval of the Licensing Terms for the Economic Activity of Medicinal Products Importation”, and the procedure for conducting the inspection before issuing the License is approved by Order of the Ministry of Health of Ukraine No. 168 dated 27 February 2013.
In March-December 2013 all importers wishing to receive Import Licenses were able to receive them under the declarative principle, on the basis of the submitted Application and the List of the medicinal products planned to be imported, which subsequently became the Attachment to the License. As promised, the issuance of Licenses was conducted under the “express method” without any additional questions concerning the documentation and without any inspection of the warehouse itself.
Validity term of the License for import of medicinal products is unlimited, and it allows to import into Ukraine only the medicinal products listed by the importer. In order to obtain the License to import medicinal products it is necessary to have the License for wholesale and retail trade of medicinal products. When marketing narcotic substances or precursors it is required to have the corresponding License.
Since December 1, 2013 the State Administration of Ukraine on Medicinal Products started to conduct scheduled and unscheduled inspections of subjects to check the fulfillment of the licensing requirements. The first stage of inspections involved the fulfillment of the licensing requirements for personnel, premises and equipment, compliance with the storage rules, quality control, complaints and recall handling, compliance with the rules for issuing the sales authorization, and the availability of importer's dossier.
Taking into consideration the long-running process of reorganization of the State Service of Ukraine on Medicines and significant shortage of personnel, not all importers were verified on a scheduled basis to date.
Cratia can perform services related to preparation of a company for the forthcoming inspections as to compliance with the license requirements, as well as obtaining the Import License, namely:
- physical audit of the warehouse, analysis of the available documentation;
- development of importer's dossier;
- completion of the current documentation or full turn-key development of the documentation of the pharmaceutical quality management system, including the standard operating procedure (SOP), standard work methodology (SWM), instructions and other documentation;
- training of personnel, implementation of the quality management system;
- preparation of the Application and documentation, obtaining the Import License for medicinal products.
Our employees have the necessary qualifications and knowledge to conduct the audit, to draw up the corrective action plan, to write importer's dossier “from scratch”, to prepare the standard operating procedures (SOP) and to train the staff.
The Import License is issued on the basis of the submitted Application (Appendix 1) and the package of documents in a 10-day period (without inspecting importer's warehouse). The cost of issuing the License is 17.00 UAH (approximately 1 (one) USD).
Reissuance of the Import License for medicinal products occurs in the following cases:
- change of the name of the legal importer;
- change of location of the legal importer.
In order to reissue the License it is necessary to submit the Application (Appendix 6) for reissuance within 10 days. The cost of issuance is 85.00 UAH (approximately 4 USD). The previous license is to be canceled.
Each branch of a legal importer of medicinal products must have a copy of the License and the Attachment. When a new branch is created it is necessary to obtain a License copy, which is issued on the basis of the Application (Appendix 5). The cost of issuance is 17.00 UAH (approximately 1 USD).
Amendments to the list of the medicinal products allowed for import, which are specified in the Attachment to the License, are made upon written request in free format by the licensee, with submission of the updated list.