An application for approval of placing on the market of medicinal product batches with labelling in other than the Czech language (“foreign language batches”) is considered justified when it is necessary in respect of the protection of public health, to ensure the availability of a particular medicinal product.
The placing on the market of foreign language batches is subject to the following conditions: there is no equivalent medicinal product with labelling in the Czech language authorised or marketed in a sufficient amount for needs of the patients in the Czech Republic and the requirements set out in Section 3 para 6 (b) of Decree no. 228/2008Coll., on the marketing authorisation of medicinal products, as amended (hereinafter referred to as the “Marketing Authorisation Decree”), are fulfilled (see detailed information below).
The applicant shall submit to the State Institute for Drug Control an application as a cover letter specifying:
- the SÚKL Code, medicinal product name, pharmaceutical form, strength and marketing authorisation number;
- number of packages applied for (number of packages should correspond to the actual need resulting from unavailability of the medicinal product with Czech labelling); the applicant shall also specify the presumed duration of the medicinal product’s lack of supply;
- language appearing on the labelling;
- batch identification (it must be consistent with the analytical certificate/batch release certificate) for which the application is being submitted;
- justification of the application for a foreign language batch, stating in particular the public health risks in case of unavailability of the medicinal product,
- the applicant’s declaration stating that each package will contain an approved package leaflet in the Czech language; the applicant specifies the date of revision of package leaflet and the method how will be the package leaflet affixed to each packaging (e.g. with a rubber band or externally) or how otherwise will be ensured that the patient receives the relevant package leaflet, and
- information whether the packages of the batch of the product bear the safety features; if the medicinal product is subject to the regulation on safety features, the applicant shall indicate whether the packages have been tampered with anti-tampering device (ATD) and whether is possible to verify and decommission unique identifier (UI) in the Czech Republic.
The applicant shall also submit a mock-up of the outer packaging, or as applicable, the immediate packaging when the outer packaging does not exist, in which the medicinal product of the foreign-language batch will be imported to the Czech Republic. The essential data, i.e. the product name, strength, pharmaceutical form, active substance, package, storage conditions and expiry date shall be consistent with the terms of marketing authorisation in the Czech Republic and should be deductible from the foreign language text or shall be added on the labelling in the Czech language. When the labelling does not comply with any of the above conditions or is not in the Latin alphabet, the proposed text of labelling in Czech shall be submitted. The approved text must be added on the labelling in the form of a "stick-over label" or reprint. Together with the application shall be submitted the foreign-language text of the package leaflet, which is included in the packaging distributed in the Czech Republic.
Note: Any stick-over may be performed only by a company authorised for such operation.
Due to amendments to the Marketing Authorisation Decree it is not necessary to add the marketing authorisation number of the medicinal product in the Czech Republic, the European EAN code different from the Czech EAN code (from 1st November 2018) and marketing authorisation holder (from 8th March 2022) on the labelling.
The application shall be accompanied by certificates of analysis/batch release certificates for the individual batches concerned, providing information on the expiry date and proof of release on the market into the EU.
The expert activities performed within procedure related to granting approval for placing on the market of foreign language batches are subject to costs reimbursement in the amount set by decree no. 427/2008 Coll., on setting the amount of reimbursement of costs conducted by the State Institute for Drug Control and the Institute for Veterinary Biologicals and Medicines, as amended. The amount is 4 500 CZK (code R-012) and shall be paid prior to submission of the application. For payment please follow the instructions in SUKL guideline UST-29. The applicant shall state in the application the variable symbol generated for the above stated payment.
Note: under Section 112 para 3 (b) of Act no. 378/2007 Coll., on Pharmaceuticals and on Amendment to Some Related Acts (the Act on Pharmaceuticals), as amended, the above mentioned requirement for reimbursement of costs does not apply to orphan medicinal products. In such case the applicant shall state in the application that he applies for a waiver in accordance with the above stated provision because his application for placing on the market of foreign language batches relates to an orphan medicinal product.
The application for placing on the market of foreign language batches shall be filed by the relevant marketing authorisation holder or a person acting on behalf of the marketing authorisation holder on the grounds of a power of attorney. An authorised person (attorney) shall be a legal or natural person, authorised by the marketing authorisation holder in accordance with section 33 of the Administrative Procedure Act to act on his behalf in proceedings with State Institute for Drug Control; such person shall prove his/her authorisation by a power of attorney in writing. Where the power of attorney is granted for an indefinite number of proceeding held on a particular subject-matter that will commence in future the signature of a person granting power of attorney must be officially authenticated. If a power of attorney has been already submitted to State Institute for Drug Control, it is not necessary to re-submit it with the application for placing on the market of foreign language batches. More information on powers of attorney is available here.
Expert Activity Coordination Department
9. 4. 2020
Updated 1. 3. 2024