Consultation – Medicine Shortage and Availability

How to proceed when requesting consultation

Persons interested in consultation (hereinafter referred to as the applicant) shall contact the Department of medicine shortage and availability via email marketreport@sukl.gov.cz.

Areas of responsibility under the Department of medicine shortage and availability

• non-authorised medicinal products
  • Specific Therapeutic Programmes,
  • Application for approval to import a medicinal product from a third country,
  • Reporting of the use of an unauthorized medicinal product (in CZ only);
• foreign-language batch,
• agenda related to medicinal products marked with the “limited availability” status – Reporting of stocks of medicinal products,
• Launch, interruption, renewal or cessation of a medicine on the market,
• Letter for healthcare professionals related to the availability of a medicinal product (in CZ only),
• Other topics related to the medicine shortage and availability.

Upon initial contact, the applicant shall submit a preliminary request for consultation, which must include specific inquiries or areas to be covered by the proposed consultation, the estimated duration of the consultation, suggested dates for the appointment, and the name, phone number, and email address of the contact person.

The applicant will be contacted by a consultant of the department.

The applicant then may submit a formal request for a consultation via email to assistant of the department. The request for a consultation must include:

• specific inquiry / inquiries (with supporting documentation, where applicable),
• the agreed duration of the consultation,
• scheduled date,
• the number and names of the participants,
• the name, phone number, and email address of the contact person,
• registered company name,
• company address,
• Company Identification Number,
• payment reference number (in the case of a paid consultation).

Furthermore, the applicant should follow the instructions of the department consultant.

To obtain a payment reference number, please shall complete the form Interactive form for application related to covering expenditures for expert activities conducted upon request and administrative fees – Covering expenditures – General  and select payment category O-001 One-hour oral consultation or issuance of a written opinion concerning regulation upon request in a scope corresponding to a one-hour consultation (not related to a pending application).

The consultation fee may be paid before or after the consultation.

• If paid in advance, the consultant will provide the applicant with a receipt confirming payment of the fee for professional services provided during the consultation.
• If paid after the consultation, a receipt for the professional services will be mailed to the applicant once the payment has been processed.