Administrative Procedure Regarding Permission of Distribution, Dispensing, Placement on the market or Use of a Medicinal Product

General information and requirements for the possibility to initiate an administrative procedure regarding permission to distribute, dispense, place on the market, or use of a medicinal product in compliance with Section 13(2)(m) and Section 23(2)(b) of the Act on Pharmaceuticals, as amended.  

Pursuant to Section 13(2)(m) and Section 23(2)(b) of the Act on Pharmaceuticals, as amended, in cases of identified quality defects of pharmaceuticals that do not pose a threat to the life or human health, the Institute decides whether the respective pharmaceutical or its individual batch may be distributed, dispensed, placed on the market or used in the healthcare services delivery 

In the mentioned case, the administrative procedure shall be initiated ex officio by the delivery of announcement of administrative procedure initiation to the Party to the Procedure, i.e. the marketing authorisation holder, where quality defects of pharmaceuticals authorised in the Czech Republic are concerned.  

In respect of the possibility to initiate an administrative procedure as referred to under Section 13(2)(m) of Act No 378/2007 Coll., on Pharmaceuticals, regarding permission to distribute, dispense, place on the market or use in healthcare service delivery a pharmaceutical for which a quality defect not presenting a threat to the life or human health has been identified, the Institute informs that it is not competent to provide its opinion on uncertified batches or the certification process. Certification and release from manufacture is the exclusive responsibility of the manufacturer's Qualified Person. Where a nonconformity of a yet uncertified batch with the marketing authorisation dossier is identified, the manufacturer may, within the scope of their internal processes, perform a correction of the batch, and only then certify the batch of the medicinal product. A quality defect arises upon certification, i.e. release from manufacture by the manufacturer's Qualified Person.

 

The Institute may hence initiate an administrative procedure only in respect of batches that have been certified by the manufacturer's Qualified Person.

Motions to initiate an administrative procedure is needed to send to zavady@sukl_cz and must meet the following requirements:

  1. An exact description of the quality defect (what the nonconformity with the marketing authorisation dossier is); in case of EU marketing authorisations, the relevant decision of the variation approval including the implementation date.
  2. A list of all batches affected by the quality defect whose shelf-life has not expired, including other additional information provided in the table below.
  3. The Analytical a Batch release certificates for all of the concerned batches.
  4. Samples of all the concerned batches, eventually their photo documentation (inner and outer packaging from all sides, leaflet inserted in the packages of the concerned batches).
  5. A risk analysis considering the impacts of the quality defect upon the patient's health.
  6. Determination the root cause of the quality defect including the proposal of corrective and preventive actions.

Annex to motion to initiate an administrative procedure pursuant to Section 13(2)(m) of the Act on Pharmaceuticals.xlsx, soubor typu xlsx, (11.01 kB)

Where several batches or strengths of the medicinal product are involved, it is advisable to initiate a single administrative procedure for all the concerned batches.

Once the Institute receives all the aforementioned documents and information, it shall assess the possibility to initiate the administrative procedure.

Information on permissions to distribute, dispense, place on the market or use medicinal products in the  of health care services delivery in compliance with Section 13(2)(m) of Act No 378/2007 Coll., on Pharmaceuticals, as amended, shall be published on the Institute's website under this section.

Furthermore, please note that prior to the initiation of the administrative procedure, it is necessary to submit to the Institute a Power of Attorney or Authorisation. In case it has not been submitted and it is necessary to prepare it at first, please proceed in accordance with the information provided here.