1. How can I become a holder of authorisation of distribution of medicinal products?
The sphere of distribution is governed by the following regulations:
- Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts - Section 75 to Section 78
- Act No 500/2004 Coll., the Administrative Procedure Code, as amended
- Act No 634/2004 Coll., on Administrative Fees
- Decree No 229/2008 Coll., on the Manufacture and Distribution of Pharmaceuticals - Section 35 to Section 41, Section 42, Section 45
- Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
- Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
- Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
Prior to the commencement of the distribution activity it is necessary to apply with SÚKL for the authorisation of distribution of medicinal products. The particulars of the application are stipulated in Section 45 of Decree No 229/2008 Coll., on the Manufacture and Distribution of Pharmaceuticals and further information is also provided in SÚKL guideline DIS-8.
SÚKL shall confirm the receipt of the application and following the check of accompanying documentation may, if applicable, invite the applicant in writing to supplement it. Where the application is complete, the Institute shall, following the verification of compliance with requirements set forth by the law and the implementing regulations, including an on-site inspection carried out by the inspectors of the Institute, issue a decision on the authorisation of distribution of medicinal products. The timeline for processing the application is 90 days.
2. I am a distributor with a distribution authorisation from another EU Member State where the company has also its registered office. Can I distribute medicinal products also within the territory of the Czech Republic?
Yes, it is possible (Section 75, paragraph 4 of the Act on Pharmaceuticals refers) in the case of a person who has obtained a distribution authorisation in any of the Community Member States. This distributor is obliged to notify SÚKL (guidelines DIS-10) in advance of its commencement of distribution in the Czech Republic, to evidence its distribution authorisation issued by another Member State, to provide contact details (address of the registered office, tel., fax, email) and other information on the scope of distribution and on the location of distribution warehouses. Furthermore, the duty to report supplies of distributed human medicinal products (guidelines DIS-13) shall be applicable thereto. If, however, such distributor establishes distribution warehouses in the Czech Republic, the duty to obtain distribution authorisation from SÚKL in advance shall be also applicable thereto.
3. Is it possible to import medicinal products also from third countries?
With respect to import of medicinal products from third countries, such activity may only be carried out by a person who has obtained an authorisation to manufacture medicinal products in the scope of import from third countries (hereinafter referred to as the “importer”). A distributor will no longer be able to carry out import of medicinal products from third countries, without being the holder of manufacturing authorisation in the scope of import from third countries.
The following approaches may be applied to import from third countries:
a) The import is conducted solely by the importer of medicinal products who carries out the receipt, storage and certification of the imported batch;
b) The import is conducted by the importer with the involvement of its contracted manufacturing sites. These contracted sites arrange for the receipt and storage of the imported batch prior to certification by the importer's qualified person.
In compliance with good manufacturing practice, a manufacturing relationship has to be contracted between the importer of the medicinal product and the contracted manufacturer to cover the area of storage of the batch originating in a third country and not yet released by the importer’s qualified person. In these cases the manufacturing process has not been completed as yet and the batches manufactured in a third country are hence not released by the qualified person of the importer in the EU. For this reason it has to be stored in a quarantined manufacturing warehouse. Distributors of medicinal products do not have manufacturing warehouses (herein in terms of the storage of a batch for which the manufacturing process has not yet been completed), unless they have obtained manufacturing authorisation in the scope of import from third countries.
4. Is it necessary for an entity which distributes only active substances and solely to manufacturers of medicinal products to be a holder of distribution authorisation?
No, distribution authorisation is not necessary for the conduct of this activity. The distribution of active substances and excipients is subject to authorisation only if the active substances and excipients are supplied to persons authorised to prepare medicinal products.
5. What are the basic obligations of a distributor?
The rights and obligations of a distributor are defined in Section 13 and Section 77 of the Act on Pharmaceuticals.
A basic overview of obligations:
- to obtain medicinal products only from other distributors or from manufacturers who manufacture or import these medicinal products;
- to distribute only to persons authorised by law;
- to have an effective system of recalls of medicinal products;
- to maintain records in appropriate extent as required by the law;
- to comply with the rules of good distribution practice;
- to cooperate with the employees of bodies authorised to carry out inspections;
- to report, on a regular basis, supplies of human medicinal products to SÚKL.
6. What are the requirements for reporting of the volumes of distributed medicinal products (DIS-13 report)?
Pursuant to Section 77(1)(f) of the Act on Pharmaceuticals, the distributor is obliged to regularly submit to the Institute complete and accurate reports of the volumes of distributed medicinal products. The structure of the data, form, method, and time intervals of the provision via electronic reports are stipulated by Section 35b of Decree No 229/2008 Coll., on the Manufacture and Distribution of Pharmaceuticals. Furthermore, distributors may be guided by the current version of guideline DIS-13, which is of the nature of a recommendation and describes, inter alia, technical information about the reporting system.
For more details on the DIS-13 report, please refer to the reporting portal at pristupy.sukl.cz.
- Can a distributor be penalised for failure to submit the DIS-13 reports or for provision of reports with inaccurate data?
7. When it is possible to obtain a GDP certificate for distributor of medicines and what the certificate documented?
GDP certificate for the distributor of medicinal products is issued by the Institute since 2. 4. 2013 in accordance with the requirements of the legislation within 90 days from the date of termination of the inspection. The issued certificate attests that the distributor carries out the obligations and is regarded as a body fulfilling the requirements of good distribution practices as provided for in Article 84 of Directive 2001/83 / EC, as amended, and § 77 par. 1 point. g) of the Act on Pharmaceuticals. It is issued after an inspection for each storage place of the distributor in particular. The validity is determined by a maximum of 5 years, but in justified cases it is possible to limit its. Restrictions may relate to the period of its validity as well as to the scope of the certified distribution activities. Furthermore it is possible to obtain a GDP certificate in the context of operations performed by the Institute on request.
8. I hold the authorization for the production of another EU Member State, where is also the headquarters of the company. Can I distribute the medicines in the Czech Republic?
Yes, it is possible (see § 75 para. 5 of the Act on Pharmaceuticals). Manufacturer of medicines is authorized to perform the activities of the distributor in the case of medicinal products manufactured in or imported from third countries. In the case of manufacturing authorization granted by the competent authority of another Member State, is for the subject valid assignation to § 75 para. 4 of the Act on Pharmaceuticals similar - see answer to a question no. 2.
9. Must all supplies of medicinal products accompanied by a certificate of analysis (CoA) and / or batch release certificate by the manufacturer of the medicinal product (CoC)?
No, but they must be documented for all batches of medicinal products intended for distribution in the Czech Republic or other EU and EEA countries which were delivered to the Czech Republic from another Member State. Before the commencement of distribution of such medicines the distributor must verify that a certificate or another document declaring the release of a batch by a medicinal product manufacturer signed by a qualified person in accordance with Art. 51 of Directive 2001/83 / EC was issued and have the relevant document or its copy at disposal.
10. What should be done when the batch number of a supplied medicinal product does not correspond with the delivery documentation (delivery notes, invoices ...)?
In such a case it is necessary to quarantine the medicines and inform the supplier of their error. The correction of the document or returning of the delivery of medicines can be agreed upon with the supplier. In case of returning the deliveries of medicines one proceeds in accordance with the process for complaints against the supplier. Medicines can be taken into stocks only upon having received the corrected documentation. (Drugs must always be put into stock in accordance with their accompanying documentation).
11. What can be a terminal (cross-dock) in connection with the distribution activity?
The term “cross-dock” or “reloading point” in connection with the distribution of medicines is admitted by Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), in which it is stated that „If the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and security of any intermediate storage facilities”. “Cross-dock” or “reloading point” when used in connection with the shipment must meet the same requirements for good distribution practice as a storage area approved for distribution of medicines. Conditions for their use and the procedures for the performed activities must be described in the documentation of the distributor (WDA holder), and these areas should be included in internal inspections carried out by the WDA holder.
cz