Registration of Importers, Manufacturers, and Distributors of Medicinal Substances

Every physical and legal entity wishing to engage in the import, manufacture, and distribution of medicinal substances within the Czech Republic must obtain official permission to conduct such activities.

Objectives of the procedure:

ensuring the availability of safe and effective drugs to the population;
checking the compliance of medicinal substances with European quality standards;
monitoring and eliminating deviations from production standards;
preventing the spread of counterfeit medicinal substances and drugs made from them.

Definition of “medicinal substance”

A substance considered medicinal is one that can be included in the composition of pharmacological drugs to affect the physiological processes of the body.

Permission for the production, distribution, and import of medicinal substances

Only official legal and physical persons authorized for entrepreneurial activity are entitled to produce, supply, and import from countries not part of the European Union (EU) and the European Economic Area (EEA), medicinal substances used in humanitarian pharmaceuticals.

A physical or legal person must register in a database controlled by the European Medicines Agency. The registration is conducted by the State Institute for Drug Control (hereinafter referred to as the Institute).

Within 60 days of registration, the Institute will decide on conducting an inspection of the applicant. If the inspection finds no legislative violations, the Institute will allow the applicant to begin activities (details on the conditions for starting activities are provided below).

Who does not need to obtain permission

Entities that supply medicinal substances exclusively to manufacturers of humanitarian medicinal drugs do not need a distribution permit.

However, all physical and legal entities in this category must notify the State Institute for Drug Control of their planned activities no later than 60 days before their commencement.

Procedure for submitting a notification to the State Institute for Drug Control

The notification is submitted in the form of a prescribed form, which must be filled out according to the following requirements:

a separate form is filled out for each location of production, import, or distribution;
the first part of the form “Production Operations” is filled out separately for each medicinal substance if the manufacturers of medicinal substances perform operations specified in sections A, B, C, and D of the first part;
if the manufacturer only performs primary/secondary packaging, they may list all medicinal substances in the heading of the first part.

Information in the forms must be provided in Czech and English. Institute staff enter the data into a European database, which is maintained only in English.

Who else must submit a notification?

The following must also notify the institute about the planned start of their activities:

drug manufacturers importing medicinal substances from non-EU and non-EEA countries for their own production; importers, manufacturers, and distributors of medicinal substances intended for pharmacy compounding.

When is it not necessary to submit a notification?

The obligation to submit a notification does not apply to distributors of medicinal substances used in investigational humanitarian medicinal products and veterinary medicinal products.

When can activities begin after submitting a notification to the State Institute for Drug Control?

Within 60 days from the receipt of the notification, the Institute must inform the applicant of the date of the inspection. The applicant may begin activities if the Institute:

conducted the inspection and based on its results issued a permit to operate;
conducted the inspection but did not inform the applicant of the results;
did not notify of the inspection date within 60 days;
informed of the inspection date within 60 days but did not conduct it within the appointed time.

How to make changes to the data provided in the notification to the State Institute for Drug Control?

The applicant must notify the Institute of any changes in the information entered in the form. Immediately report:

changes in the company name, location of the office and production (import, distribution);
introduction of a new medicinal substance into production;
the adoption of new technologies;
significant changes in the production process.

All changes related to production must be confirmed by an SVP certificate, which guarantees compliance with good manufacturing practice. The SVP certificate is provided to the Institute along with the notification of changes.

Changes to be reported annually:

removal of a medicinal substance from the list;
addition of a medicinal substance to the list;
decommissioning of production equipment;
changes in the production process that are not considered significant for the quality of the medicinal substance.

The notification of changes is submitted on a special form. After receiving the notification, the Institute assesses the risks associated with the declared changes and, based on the assessment, may decide to conduct an inspection of the applicant.

Requirements for distributors of medicinal substances

The distributor is required to supply only those medicinal and auxiliary substances, the quality of which is confirmed by:

a control laboratory with an official permit to operate;
the manufacturer of medicinal and auxiliary substances;
the manufacturer of the raw materials from which the medicinal substances are made.

The supply must be carried out in a manner permitted by law.