Decree of the Ministry of Health and the Ministry of Agriculture No. 21 / 1998 Coll.
Ordinance of the Ministry of Health and the Ministry of Agriculture on reserved medicines and good practice of drug dealers
Valid
Effective from 03.02.1998
21
DECLARATION
Ministry of Health and Ministry of Agriculture
of 30 January 1998
establishing reserved medicines and good practice for dealers of reserved medicines
The Ministry of Health and the Ministry of Agriculture, pursuant to § 75 (2) (h) and (g) of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws, hereinafter referred to as "the Act ':
Subject matter
This decree provides for:
the correct practice of dealers of reserved medicines in order to maintain the quality, safety and efficacy of those medicines.
The classification of a medicinal product as a reserved medicinal product is decided by the State Institute for Drug Control in the Marketing Authorisation Regulation (1a) and publishes their list in each calendar year in the Bulletin of the State Institute for Drug Control (1b).
Good practice of drug dealers
(1) Sellers of reserved medical2) in addition to the obligations laid down by law are required
(a) to buy reserved medicines with a shelf life of at least six months;
(b) reserved medicines
1. transport in such a way as to avoid damage to their packaging and to alter their physical and chemical properties, in particular as a result of mechanical or thermal effects or moisture,
2. store separately in dry, well ventilated rooms to protect it from light, contamination with other stored substances and animal intrusion; the temperature at the place of storage shall not exceed 15 ° C to 25 ° C unless otherwise specified on the packaging of the reserved medicines or in the package leaflet of the medicinal products;
3. to check that there is no reason for their withdrawal,
(c) ensure that the unused medication3) is separated from the medicines applicable until they are disposed of.
(2) Reserved medicinal products must not be sold in the form of stand, service, mail or delivery sales.
(3) When handling and selling reserved medicines,
(a) the hygiene requirements laid down by the Ministry of Health are respected, 5)
(b) evidence of the acquisition of reserved medicines from a domestic manufacturer or distributor is available. 6)
Efficacy
This decree shall take effect on the day of its publication.
Minister for Health:
MUDr. Roith, M.B.A. v. r.
Minister for Agriculture:
Ing. Lux v. r.
(1a) Paragraph 25 (2) (c) of the Act.
(1b) Paragraph 9 (2) (e) of the Law.
2) Paragraph 18 (4) of the Act.
3) Articles 18 (4) (d) and 50 (1) of the Act.
4) Paragraph 18 (4) (f) of the Act.
5) § 19 of Decree of the Ministry of Health No. 45 / 1966 Coll., on the creation and protection of healthy living conditions.
6) Paragraph 18 (4) (g) of the Act.
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Regulation Information
| Citation | Decree of the Ministry of Health and the Ministry of Agriculture No. 21 / 1998 Coll., establishing reserved medicines and good practice of dealers of reserved medicines |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 03.02.1998 |
|---|---|
| Effective from | 03.02.1998 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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