New Rules of the Licensed Terms for Production, Trade and Import of Medicinal Products were Offered

On 13.07.2015 The Ministry of Health of Ukraine published the draft resolution of the Cabinet of Ministers of Ukraine "About approval of the Licensed terms of realization of economic activity related to the production of medicinal products, wholesale and retail trade of medicinal products, import of medicinal products (except active pharmaceutical ingredients)" on its website for public discussion.

New licensed terms essentially united licensed terms of production and trade of medicinal products and of import of medicinal products, which currently have been approved as two different legal acts.

Fixed places of activity conduct for each definite type of the activity became an important innovation for the Draft resolution. For example, production (manufacturing) of medicinal products within the conditions of a pharmacy must be held in a pharmacy; wholesale - in a pharmacy warehouse (base), retail business - in a pharmacy, pharm point, import (except АPI) - in a warehouse zone (building for storage, warehouse), in a zone of realization of delivery of permission on producing (realization) of series of medicinal products.

Thus in an application on a receipt of a license it is necessarily to mark all places of realization, where the person intends to carry out the activity. In addition, an applicant shall submit necessary documents for confirmation of factual conduct for each place of activity conduct. It shall be noticed, that carrying out the activities out of such places is forbidden by effective legislation.

Information about places of activity conduct should be registered in the Unified State Register of Legal Entities and Individual Entrepreneurs. It is defined by the Draft resolution that when a licensee establishes a new place of carrying out the activity, he shall submit an application about adding such information to the Unified State Register of enterprises and organizations of Ukraine (EDRPOU) to the State Services of Ukraine on Medicinal products.

The Draft resolution also contains the exhaustive list of confirmative documents for each type of the activities that should be licensed.

In addition, for production this function will be carried out by the dossier copy of the production place, which was approved by the business entity; for the production (manufacturing) of medicinal products in the pharmacies, wholesale and retail trade - information signed by the applicant - business entity about availability of logistical base and qualification level of employees, required for appropriate business entity to import drugs (besides of active pharmaceutical ingredients) - copy of the importers dossier, approved by the business entity, of the prescribed form.

Attention should be also paid on the fact that the Draft resolution stipulates several ways of filling the documents to obtain the license on the choice of the applicant.

As well as under the law of Ukraine «On licensing of types of economic activity», it is possible to submit the documents personally, by postal mail with description and in the electronic way.

The Draft resolution also determines terms of consideration of application and adoption of the decisions by the State Services of Ukraine on medicinal products.

Moreover, according to the Draft resolution, authorized persons of the State services of Ukrainian on medicinal products are given additional authority to review the documents, which is necessary to obtain a license. Whereas pursuant to the currently effective licensed terms it is stated that after processing of the submitted documents, an official may either decide to obtain or decline to issue the license, according to the Draft resolution they may leave the application without consideration. To adopt such a decision, the Draft resolution defines an exhaustive list of grounds, namely:

1) signed documents, added to the application for a receipt licenses, are not given in full;

2) application or even one of the documents added to the application about the receipt of license:

• signed by person who does not have powers on it;
• issued with violation of requirements of The Law of Ukraine «About licensing of types of economic activity», does not comply with the set form or does not contain information which should be necessarily brought in it;

3) application was submitted after the expiry of the term, stated under part second of clause 1.18 of this section;

4) absence of the information about the licensee (business entity) in the Unified State Register of Legal Persons
and Individual Entrepreneurs or presence of information about state registration of its termination.

After the grounds which became reasons for the receipt of license without consideration have been fixed, the applicant may submit an application about its receipt again.

The Draft also changes a term for the payment for the delivery of the license. If under the effective licensed terms a payment is carried out during thirty days from the day of sending of the report about a decision-making about license, according to the Draft resolution this term is shorten up to ten business days.

It is important to mention, that Draft resolution declares the additional type of control, that is held just before the licensed verification, which is not stipulated under current legislation. Such verification in accordance with the Draft will be carried out in the case of opening the new place of conduct of economic activity by the licensee and prior to making alteration in EDRPOU.

Please notice that in accord with the effective legislation a receipt of the new license in the case of opening of new place of conduct of activity is not required.

Thus, under the Draft resolution it is set general provisions that determine, how an applicant applies to the organ of licensing, with what statements, and also the forms of these statements are unified. By the Draft resolution the list of general organizational requirements was included, stated under the law «About licensing of types of economic activity», and separate rules are set for each of types of the economic activities in the field of circulation of the medicinal products.