An appeal from the decision of the State Institute for Drug Control taken pursuant to Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals) may be filed with the State Institute for Drug Control within 15 days of the notification of the decision to the party to 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
- Name of the applicant (person filing the appeal);
- Identification of the State Institute for Drug Control;
- Identification of the decision disputed by the appeal;
- Where the applicant finds grounds for a breach of law, and where he/she finds the decision or preceding procedure to be incorrect;
- What the person filing the appeal claims;
- Signature of the person filing the appeal.
Methods of filing an appeal
Státní ústav pro kontrolu léčiv
- By post to the following address:
100 41 Praha 10,
- Personally, in the mail room of SÚKL (at the same address as the one specified for postal delivery),
- Via electronic mail room at posta@suklcz 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 of SÚKL.