Decree of the Ministry of Health No. 157 / 2001 Coll.
Decree of the Ministry of Health amending Decree of the Ministry of Health No. 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for medical regulations and the rules for their use
Valid
Order
Effective from 01.07.2001
Text versions:
01.07.2001
04.05.2001
157
DECLARATION
Ministry of Health
of 26 April 2001
amending Decree of the Ministry of Health No 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for medical prescriptions and the rules for their use
In agreement with the Ministry of Agriculture, the Ministry of Defence, the Ministry of Interior and the Ministry of Justice pursuant to § 75 (3) 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 343 / 1997 Coll., laying down the procedure for the prescription of medicinal products, the formalities for and the rules for their use, shall be amended as follows:
1. in Article 2 (1), the words "points 2 and 3 'shall be inserted after the words" Article 1 (a)';
2. Paragraph 2 (4) is deleted.
3. after Article 2, the following Section 2a is inserted:
Handling of recipes and requests marked with blue stripe
(1) The recipes and applications forms marked with a blue stripe (§ 3 (4)) are subject to registration.
(2) The production and distribution of recipes and applications, marked with a blue stripe, are provided by the local competent district authorities on the basis of orders from persons operating health or constitutional welfare facilities (4a) or by natural or legal persons authorised to perform professional veterinary activities (4b) (hereinafter referred to as authorised persons), with the place of performance of those activities in the administrative districts of the district offices for which they order the forms. On the basis of these orders, the county authorities will ensure the production of recipes and requests marked with a blue stripe by the contracted manufacturer.
(3) In order to ensure the smooth distribution of recipes and requests marked with a blue stripe, the district authorities shall create an emergency supply of these forms, within a maximum of one fifth of their total distribution over the previous calendar year.
(4) The recipes and applications forms marked with a blue stripe must be accompanied by the particulars in accordance with the models set out in Annexes 1 and 2 and shall be taken from the manufacturer by the authorised representative of the district office. The authorised staff member shall prove to the manufacturer on receipt of the forms in force by delegation and shall acknowledge receipt by signature and stamp of the district office.
(5) The County Office shall register and invite the authorised person to pick up the recipes and requests marked with a blue stripe after taking over. Prescription forms and requests marked with a blue stripe may only be issued by district authorities to authorised persons through their authorised representatives. (c)
(6) On the issue of the forms, the district office shall keep a register of the forms containing information on the number of forms issued, including the serial numbers of the forms and information on the authorised person. The receipt of the form shall be confirmed by the authorised representative on the original order and by the signature in the form book.
(7) Where authorised persons issue prescription forms and applications marked with a blue stripe to persons having an employment relationship or similar relationship, the holder shall keep a record of such expenditure in accordance with paragraph 6.
(8) Impaired prescription forms and requests marked with a blue stripe shall be submitted to persons to whom such forms have been issued by an authorised person before the impairment.
(9) The authorised person shall keep a record of the discarded prescription forms and requests submitted. Submit of the invalidated forms, within the time limit agreed with the local competent district office, to that district office for disposal. The transmission and disposal of degraded recipes and requests marked with a blue stripe shall be subject to a protocol record by the district office and shall confirm receipt by the authorised person.
(10) The county authorities keep a record of the recipes and requests forms marked with a blue stripe returned to the county authorities for the reasons set out in the specific legislation4d.
(11) Article 2 (2) and (3) shall apply mutatis mutandis to the handling of recipes and requests marked with a blue stripe.
4 (a) Paragraph 5 (2) (a) of Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as amended by Act No. 117 / 2000 Coll. and Act No. 132 / 2000 Coll.
4b) § 5 (2) (b) of Act No. 167 / 1998 Coll., as amended by Act No. 117 / 2000 Coll. and Act No. 132 / 2000 Coll.
4c) Paragraph 13 (3) of Act No. 167 / 1998 Coll., as amended by Act No. 117 / 2000 Coll. and Act No. 132 / 2000 Coll.
4d) § 13 paragraphs 7 and 8 of Act No. 167 / 1998 Coll., as amended by Act No. 117 / 2000 Coll. and Act No. 132 / 2000 Coll. '
4. In Article 3 (1), the following shall be added at the end of point (a): "flunitrazepam or '.
5. Annex 1 shall read:
6. Annex 2 shall read:
Transitional provision
The county authorities holding a stock of recipes and requests, marked with a blue stripe corresponding to the models provided for in the existing legislation (9), may use those forms until stocks are exhausted, but no later than 31 December 2002, if they are supplemented by the data set out in Annexes 1 and 2.
Efficacy
This Decree shall take effect on 1 July 2001.
Minister:
Prof. MUDr. Fisher, CSc.
9) Annexes No 1 and 2 to Decree No 343 / 1997 Coll., laying down the procedure for the prescription of medicinal products, the formalities for medical prescriptions and the rules for their use.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree of the Ministry of Health No. 157 / 2001 Coll., amending Decree of the Ministry of Health No. 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for medical regulations and the rules for their use |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 04.05.2001 |
|---|---|
| Effective from | 01.07.2001 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
Comments 0