Decree of the Ministry of Health and the Ministry of Agriculture No. 234 / 2000 Coll.
Decree of the Ministry of Health and the Ministry of Agriculture amending Decree of the Ministry of Health and of the Ministry of Agriculture No. 90 / 1999 Coll., laying down details on the preparation and supply of medicinal products and closer conditions for the operation of pharmacies and other operators issuing medicinal products
Valid
Order
Effective from 01.08.2000
234
DECLARATION
Ministry of Health and Ministry of Agriculture
of 19 July 2000
amending Decree No. 90 / 1999 of the Ministry of Health and the Ministry of Agriculture Coll., laying down details on the preparation and supply of medicinal products and closer conditions for the operation of pharmacies and other operators issuing medicinal products
The Ministry of Health and the Ministry of Agriculture provides, pursuant to § 75 (2) (e) of Act No. 79 / 1997 Coll., on Medicines and on amendments and additions to certain related laws, hereinafter referred to as "the Act ':
Decree No. 90 / 1999 Coll., laying down the details of the preparation and supply of medicinal products and the detailed conditions for the operation of pharmacies and other medicinal product-issuing operators, is hereby amended as follows:
1. in Paragraph 1, point (b) is deleted;
Points (c) to (j) shall be renumbered (b) to (i).
2. In Article 1, at the end of point (i), the dot is replaced by a comma and the following point (j) is added:
"(j) by triturating a mixture of a well-wiped active substance with an appropriate excipient, usually lactose, in a proportion which allows accurate weighing of the active substance."
3. In Article 2, the following paragraph 8 is added:
"(8) The preparation of medicinal products shall also be considered as
(a) consideration;
(b) filling,
(c) the distribution of individual packages of mass-produced medicinal products for sleeper medical devices. ';
4. in Article 5 (1) (e):
"(e) in addition to the labelling referred to in points (a) to (d), with the warning text" Flammable and auxiliary substances "for flammable and corrosive active substances and" Irritants "for corrosive and toxic substances."
5. In Paragraph 5 (2), at the end of point (p), the dot is replaced by a comma and the following point (r) is added:
"(r) the words" Flammable "in the case of flammable medicinal products and the words" Thirsty "in the case of corrosive medicinal products."
6. In Article 6, the following paragraph 4 is inserted after paragraph 3:
"(4) For medicinal products re-prepared for request1), their preparation and inspection shall be carried out in accordance with a pre-established technological regulation (§ 11 (3))."
Paragraphs 4 and 5 shall become paragraphs 5 and 6.
7. In Article 10 (5), "Seperanda 'is replaced by" Separanda'.
8. in Article 11 (2) (a) (1), the words "including their batches" shall be inserted after the words "manufactured medicinal products."
9. In Article 11 (2), the dot at the end of point (h) is replaced by a comma and the following point (i) is added:
"(i) records of stocks of the intake and supply of medicinal products, by item, allowing a distinction between the pharmaceutical form, the quantity of the active substance contained in the unit of mass, volume or unit of the pharmaceutical form and the package size of the medicinal product including the code of the medicinal product."
10. Paragraph 11 (3), including footnote 29a, reads:
"(3) The technological regulation dated and signed by the person responsible (29a) contains the procedure for the self-preparation of the medicinal product, including the quantity of the active substance in the unit of mass or volume and the procedures for carrying out the checks on the preparation and the extent of such checks, indicating the values to be achieved during those checks. The technological regulation shall be kept up to date and the changes made shall be marked in such a way that the original text, dated and signed by the responsible person, is legible. 29a) The technical regulation withdrawn from use shall indicate the expiry date and be signed by the responsible person. 29a)
29a) § 21 (1) (d) of the Act. '
11. in Article 11 (4), the words "except for the register referred to in paragraph 2 (i), which shall be kept for a period of 3 years," shall be inserted after the words "last entry";
12. Part Four is deleted.
13. in Paragraph 31 (1) (e), the word "tinkering" is replaced by "destruction."
This Decree shall take effect on 1 August 2000, with the exception of Article I (9), which shall take effect on 1 March 2001.
Minister for Health:
Prof. MUDr. Fisher, CSc.
Minister for Agriculture:
Ing. Fencl v. r.
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Regulation Information
| Citation | Decree of the Ministry of Health and the Ministry of Agriculture No. 234 / 2000 Coll., amending Decree of the Ministry of Health and of the Ministry of Agriculture No. 90 / 1999 Coll., laying down details on the preparation and supply of medicinal products and closer conditions for the operation of pharmacies and other medicinal operators |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.07.2000 |
|---|---|
| Effective from | 01.08.2000 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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