Licence for pharmaceutical activity

The international law company “Alt-Brayer” provides consultancy and practical legal services in the field of licensing of pharmaceutical activity in all territory of Ukraine. In particular, our lawyers give the complex legal aid and maintenance of obtaining the licence for pharmaceutics, including preliminary and line consultations concerning the legislation and procedure of licensing directly.

Licence for pharmaceutical activityLicence requirements

The licence for pharmaceutical activity is the document allowing to render medical services and to carry out the sale of medicines. However, of course, if there is “admission” before such activity, for its receiving it is necessary to satisfy some more conditions which will prepare you and your enterprise for the accomplishment of the planned scope of work.

So, the main requirements for obtaining the licence for pharmaceutical practice the following:

  • availability of the room in which certain technology zones are separately placed, namely — production, warehouse, the compartment of quality control, auxiliary and warehouse;
  • availability of the alarm system: security and fire-prevention;
  • the presence of specialists with the corresponding vocational education who meet uniform qualification requirements and also have the diploma of the state sample about pharmaceutical education;
  • Availability of regulations for production of medicines (technical and technology), and also the corresponding analytical regulating documentation (medical article, technical conditions enter here).

Types of pharmaceutical licences in Ukraine

According to the Ukrainian legislation, for wholesale and retail trade by medicine it is necessary to have separate licences. Also, in the certain order, it is necessary to get permission for production of the specified preparations.

Depending on the drawn-up action plan, legal or to the natural person entrepreneur it will be necessary to receive one of these documents:

Licence for retail trade of medicines

Licence for wholesale trade of medicines

Licence for production of medicines

Legal aid with licensing

The international law company “Alt-Brayer” provides the list of services for obtaining the licence for pharmaceutical activity:

  1. The license to sell pharmaceuticalsConsultation and informing client on the legislation of Ukraine;
  2. Consultation with the client concerning obtaining the licence;
  3. Preparation and registration of the package of documents for its giving in bodies of licensing;
  4. Assistance in obtaining the allowing documents necessary for licensing of pharmaceutical activity;
  5. Filing of applications in bodies of licensing;
  6. Receiving and licensing to the client.

The successful long-term practice of our lawyers in the field of licensing of productive activity in Ukraine will tumble down “without a knot and the hitch” to issue for you the licence for pharmaceutics, having saved at the same time the mass of personal time and financial resources. We guarantee to 100% result, considering at the same time all specific features and customer requirements.