Decree No. 43 / 2004 Coll.
Decree establishing good practice of dealers of reserved medicines
Valid
Effective from 06.02.2004
43
DECLARATION
of 26 January 2004
laying down good practice for drug dealers
In agreement with the Ministry of Agriculture, the Ministry of Health provides, pursuant to § 75 (2) (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 good practice for dealers of reserved medicines in order to maintain the quality, safety and effectiveness of medicines.
(1) Sellers of reserved medical1) ensure that:
(a) there is no damage to their packaging and changes in their physical and chemical properties, in particular as a result of mechanical or thermal effects and, where appropriate, moisture, when handling the medicinal products;
(b) reserved medication2) has been stored separately, in dry, well-ventilated rooms, in such a way as to protect them from light, from contamination with other stored substances and the introduction of animals; the temperature at the place of storage shall not be contrary to the conditions laid down in the marketing authorisation for medicinal products, 3) which the seller of the reserved medicinal products keeps;
(c) the stored reserved medicinal products have been monitored for their shelf life;
(d) the medicines which are not applicable (4) have been separated from the medicines which are applicable until they are disposed of. 5)
(2) Reserved medicinal products are not sold by self-service or mail.
Repeal
The following shall be deleted:
1. Decree No. 21 / 1998 Coll.
2. Decree No. 123 / 2001 Coll., amending Decree No. 21 / 1998 Coll., laying down reserved medicines and good practice of dealers of reserved medicines.
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Dr. Součková v. r.
1) Paragraph 4 (1) (f) of the Act.
2) Paragraph 2 (15) of the Act.
3) Article 26 of the Act.
4) Paragraph 50 (1) of the Act.
5) Paragraph 18 (4) (f) of the Act.
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Regulation Information
| Citation | Decree No. 43 / 2004 Coll., establishing good practice of dealers of reserved medicines |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 06.02.2004 |
|---|---|
| Effective from | 06.02.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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