Decree No. 205 / 2018 Coll.
Decree amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended
Valid
Effective from 01.11.2018
205
DECLARATION
of 5 September 2018
amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended
The Ministry of Health shall determine, pursuant to Article 114 (1) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act No. 378 / 2007 Coll.), as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll. and Act No. 66 / 2013 Coll., and Act No. 66 / 2017 Coll., and Act No. 66 / 2017 Coll.:
Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended by Decree No. 13 / 2010 Coll., Decree No. 171 / 2010 Coll. and Decree No. 255 / 2013 Coll., is amended as follows:
1. In Paragraph 1 (1), the words "European Communities' are replaced by the words" European Union '.
2. in Article 1 (2) (a) (1) and (2), the word 'smallpox' shall be replaced by 'chickenpox';
3. In Article 3 (6) (b), the words "and the registration number in the case of veterinary medicinal products' shall be added at the end of point 6.
4. In Paragraph 3 (6) (b), at the end of point 7, comma is replaced by a dot and points 8 and 9 are deleted.
5. In Section 6 (1) of the Introductory Part of the provision, the words "To be classified as reserved human products may" are replaced by the words "Reserved medicinal products are only";
6. In Section 7a (1), in the introductory part of the provision, the words "To be classified as reserved veterinary products may be replaced by" shall be replaced by "Reserved veterinary products shall be only."
7. In Article 17 (2) (c), the words "(Article 52 (2) of the Law) 'are deleted.
8. The following Section 18a is inserted after Section 18, including the title:
Provision of data on the volume of supplies of medicinal products for human use placed on the market in the Czech Republic
(1) The Marketing Authorisation Holder provides information on the volume of supplies of medicinal products for human use placed on the market in the Czech Republic under Section 33 (2) of the Drug Act by electronic notification in the previous calendar month, no later than the 10th day of the following calendar month. The marketing authorisation holder shall provide the report even if he has not supplied any medicinal products for human use in the relevant calendar month. If the marketing authorisation holder has not launched the supply of the medicinal product, he shall not report.
(2) The marketing authorisation holder shall provide the reports referred to in paragraph 1 through the communication interface of the Institute in a way that allows remote access in an open data format. Access data and the unique identifier of the marketing authorisation holder shall be allocated by the Institute to the marketing authorisation holder upon request.
(3) The marketing authorisation holder may make adjustments or additions to the report already provided pursuant to paragraph 1 between the 10th and 20th day of the calendar month. After the 20th day of the month, the content of the report cannot be changed. Where the marketing authorisation holder finds, retrospectively after the 20th day of the calendar month, that he has provided incomplete or incorrect information in the report, he shall immediately send the Institute a corrective report.
(4) The report referred to in paragraph 1 or the corrective report referred to in paragraph 3 shall contain:
(a) the unique identifier assigned to the marketing authorisation holder,
(b) the calendar month and year for which the report is submitted;
(c) the unique message identifier assigned by the Institute;
(d) indication of whether the medicinal product has been supplied to the distributor or pharmacist,
(e) the identification of the medicinal product for human use by the code of the medicinal product for human use allocated by the Institute, the name of the medicinal product for human use, its batch and the price of the agent for which the medicinal product was placed on the market; and
(f) the number of packages of the medicinal product for human use, with a distinction between whether it has been delivered or returned. ';
Technical Regulation
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Efficacy
This Order shall take effect on the first day of the second calendar month following its publication.
Minister for Health:
Mgr. et Mgr. Vojtěch v. r.
Minister for Agriculture:
Ing. Toman, CSc., v. r.
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Regulation Information
| Citation | Decree No. 205 / 2018 Coll., amending Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.09.2018 |
|---|---|
| Effective from | 01.11.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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