Decree No. 460 / 2023 Coll.
Decree amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended
Valid
Order
Effective from 01.01.2024
Text versions:
01.01.2024
29.12.2023
460
DECLARATION
of 20 December 2023
amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended
The Ministry of Health and the Ministry of Agriculture provides, pursuant to § 114 paragraphs 1 and 2 of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act on Medicines), as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll. and Act No. 456 / 2023 Coll., to implement § 33 paragraph 2 of the Act on Medicines:
Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended by Decree No. 13 / 2010 Coll., Decree No. 171 / 2010 Coll., Decree No. 255 / 2013 Coll., Decree No. 205 / 2018 Coll. and Decree No. 27 / 2022 Coll., are amended as follows:
1. In Paragraph 3 (6), at the end of point (a), "a 'is replaced by" if'.
2. in Article 3 (6) (b), point 1 shall be deleted;
Points 2 to 7 shall become points 1 to 6.
3. In Article 6 (1), at the end of point (h), the dot is replaced by a comma and the following points (i) to (p) are added:
"(i) human medicinal products containing the active substance pantoprazole as a maximum of 20 mg per unit of pharmaceutical form, and if one pack of human product contains a maximum of 14 units of pharmaceutical form, in an indication of short-term treatment of reflux symptoms in adults,
(j) human medicines to relieve pruritus containing the active substance dimetindene for topical administration,
(k) human products containing the active substance difenhydramine for topical application,
(l) medicinal products for human use containing the active substance aciclovir for topical application, as indicated for topical treatment of fowls of the lips and face,
(m) human products containing the active substance diclofenac for topical application,
(n) medicinal products containing the active substance azelastine for topical application in the indication allergic rhinitis and conjunctivitis,
(o) medicinal products for human use covered by the medicinal product group antihistamines for systemic use containing the active substance cetirizine at a maximum of 10 mg per unit of pharmaceutical form, and if each pack of human product contains a maximum of 30 units of pharmaceutical form,
(p) medicinal products for human use belonging to the medicinal product group antihistamines for systemic use containing the active substance levocetirizine at a maximum level of 5 mg per unit of pharmaceutical form and if each pack of human product contains a maximum of 21 units of pharmaceutical form. "
4. In Article 6 (5), the words "for medicinal products subject to regulation by Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws' are deleted.
5. In Paragraph 11, the comma at the end of point (i) is replaced by a dot and point (j) is deleted.
6. In Article 12 (k), the word "sample 'is replaced by" graphic packaging' and the words "what is intended 'are replaced by the words" what is intended'.
7. In Paragraph 18a (1), the word 'tenth' is replaced by 'fifth'.
8. Paragraph 18a (3) reads as follows:
"(3) Where the marketing authorisation holder finds that he has entered incomplete or incorrect information in the report, he shall immediately send a correction to the Institute. ';
9. in Paragraph 18a (4) (a):
"(a) the identification code of the marketing authorisation holder allocated by the Institute;"
10. in Paragraph 18a (4) (d):
"(d) the identification of the person to whom the medicinal product has been supplied by the identification number of the person and the workplace identification code allocated by the Institute;"
11. the following Article 18b is inserted after Article 18a:
(1) The Marketing Authorisation Holder provides the Institute with the data referred to in Article 33 (2) of the Law on Medicines on the current quantity of the medicinal product for human use, which it has at the time of notification of the interruption or termination of the marketing of the medicinal product for human use in the Czech Republic and was designated for the marketing in the Czech Republic, at the same time as the notification.
(2) Paragraph 18a (2) shall apply mutatis mutandis for the purposes of providing the data referred to in paragraph 1.
(3) Where the marketing authorisation holder finds that he has provided incomplete or incorrect information in the report, he shall immediately send a new report to the Institute indicating the actual quantity of the medicinal product concerned.
(4) The reports referred to in paragraphs 1 and 3 shall contain:
(a) the identification code of the marketing authorisation holder allocated by the Institute;
(b) the unique message identifier assigned by the Constitution;
(c) the code of the medicinal product for human use allocated by the Institute; and
(d) the number of packages of the medicinal product for human use. ';
Efficacy
This decree shall take effect on the first day of the calendar month following its publication.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
Minister for Agriculture:
Mgr. Excellent v. r.
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Regulation Information
| Citation | Decree No. 460 / 2023 Coll., amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.12.2023 |
|---|---|
| Effective from | 01.01.2024 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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