As stipulated by Act No 123/2000 Coll., on Medical Devices

It is possible to file an appeal from the decision of the State Institute for Drug Control by way of which the Institute has decided in compliance with Act No 123/2000 Coll., on Medical Devices, as amended (e.g. a decision on the imposition of the duty to eliminate identified shortcomings within the set timeline, on a protective measure, on a fine for breach of law), with the State Institute for Drug Control within the period of 15 days of the notice of the decision to the party to the administrative procedure.The appeal shall be decided by the Ministry of Health within the timeline set forth by the provision of Section 71 of Act No  500/2004 Coll., Administrative Code, as amended, i.e. within the period of max. 60 days of the submission of the appeal together with the file by the State Institute for Drug Control who shall do so no longer than within 30 days of the delivery of the appeal.  The appeal may be also decided upon by the State Institute for Drug Control by fully granting the appeal, i.e. by way of reconsideration.The appeal cannot dispute the rationale of the decision, but only the ruling part of this decision.

What the appeal must contain

  1. Name of the applicant (person filing the appeal); 
  2. Identification of the State Institute for Drug Control;
  3. Identification of the decision disputed by the appeal;
  4. Where the applicant finds grounds for a breach of law, and where he/she finds the decision or preceding procedure to be incorrect;
  5. What the person filing the appeal claims;
  6. Signature of the person filing the appeal.

Methods of filing an appeal

In writing

  1. By post to the following address:
State Institute for Drug Control
Šrobárova 48
100 41 Prag 10,
Czech Republic
  1. Personally, in the mail room of SÚKL (at the same address as the one specified for postal delivery),
  2. Via electronic mail room at posta@sukl_cz with a certified electronic signature.
Orally to the protocol
An oral appeal may be lodged at the same address of the Institute as that for postal delivery or at any Regional Control laboratory (OKL) of SÚKL.