Act No. 149 / 2000 Coll.
Act amending Act No. 79 / 1997 Coll., on Medicines, and on the Amendments to Certain Related Acts, Act No. 20 / 1966 Coll., on the Care of People, as amended, and Act No. 455 / 1991 Coll., on Business Business (Trade Act), as amended
Valid
Law
Effective from 01.08.2000
149
THE LAW
of 16 May 2000
amending Act No 79 / 1997 Coll., on medicinal products and on the amendment and addition of certain related laws, Act No 20 / 1966 Coll., on the care of the health of the people, as amended, and Act No 455 / 1991 Coll., on business entrepreneurship (Trade Act), as amended
Parliament has decided on this law of the Czech Republic:
Amendment of the Trade Act
Act No. 123 / 2000 Coll., Act No. 600 / 1992 Coll., Act No. 83 / 1998 Coll., Act No. 157 / 1993 Coll., Act No. 38 / 1994 Coll., Act No. 42 / 1994 Coll., Act No. 136 / 1994 Coll., Act No. 200 / 1994 Coll., Act No. 72 / 1995 Coll., Act No. 49 / 1997 Coll., Act No. 61 / 1997 Coll., Act No. 95 / 1996 Coll., Act No. 147 / 1996 Coll.
1. in Article 3 (2) (a), the words "and dental technicians" shall be deleted;
2. In Paragraph 31 (12), in the sentence, the first words "is obliged to issue 'are replaced by" is obliged to issue at the request of the customer'.
3. In Annex 3 to the Concessions Group 304 in column 1, the text "Production and repair of dental expenses' is deleted; in column 2, the text" secondary vocational training in dental techniques, 6 years of experience in the field without interruption, post-graduate specialisation in educational establishments approved by the Ministry of Health (criteria apply also to professionals) 'is deleted and in column 4, the text "Ministry of Health' is deleted.
4. In Annex 3 to GROUP 307: Manufacture of chemical products, in the field of trade Purchase, storage and sale of mass-produced medicinal products which can be sold without a prescription and outside pharmacies under the marketing authorisation, in column 5 the words "paragraph 3 'are replaced by" paragraphs 4 and 7 (l)'.
TRANSITIONAL PROVISIONS
1. Sellers of reserved medicines who have acquired a trade licence to sell reserved medicines before the application of this Act are required to report this fact to the State Institute for Drug Control within 6 months of the entry into force of this Act. For failure to comply with this obligation, the dealers of reserved medicines may be fined under the Trade Act.
2. The list of reserved medicines provided for by the Decree of the Ministry of Health and the Ministry of Agriculture No. 21 / 1998 Coll., which provides for reserved medicines and the correct practice of dealers of reserved medicines, expires 12 months after the entry into force of this Act. If the marketing authorisation holder of the reserved medicinal product referred to in the Decree of the Ministry of Health and of the Ministry of Agriculture No. 21 / 1998 Coll., which provides for reserved medicines and the correct practice of dealers of reserved medicinal products, applies for a change to the marketing authorisation to be included in the reserved medicinal product (§ 2 (19) of Act No. 79 / 1997 Coll., on medicinal products and on amendments and additions to certain related laws, as amended by this Act), he shall be exempt from the administrative fee within 6 months of the date of application of this Act.
3. The establishments of the transfusion service are required, if they wish to continue their activities, within 2 years of the entry into force of this Act to obtain a permit to produce pursuant to § 41 (a) of Act No. 79 / 1997 Coll., on Medicines and on amendments and additions to certain related laws, as amended by this Act. An application for a production permit shall be submitted by the establishments of the transfusion service no later than 18 months after the entry into force of this Act. As long as the production permit is obtained, but not more than 2 years after the entry into force of this Act, it is regarded as satisfying the condition laid down. For applications submitted within 18 months of the entry into force of this Act, the time limit set for deciding to issue a production permit (§ 42 (2) of Act No. 79 / 1997 Coll., on medicines and on amendments and additions to certain related laws, as amended by this Act) is extended to 180 days. If an application for a production permit is submitted by a transfer service facility within 9 months of the entry into force of this Act, it shall be exempt from the administrative fee.
4. The period of 30 days provided for in Article 25 (1) of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws, as amended by this Act, and the period of 210 days provided for in Article 25 (2) of the Act No. 79 / 1997 Coll., on Medicines and on amendments and additions to certain related laws, as amended by that Act, shall apply to applications submitted after 1 year from the date of entry into force of this Act; applications submitted within 1 year from the date of entry into force of this Law shall be decided no later than 18 months after their receipt, the period for which the proceedings have been suspended being excluded from that period.
5. Persons who have engaged in a registered activity in the field of "Dental Laboratory" as a non-state medical institution under a special legislature (1) on 1 March 2000 and after that date in the form of a licensed trade "Production and repair of dental refunds" and who have notified the authority responsible for registration under a special legislature (1) within 1 month of the date of application of this law that they intend to continue their activities as a non-state health establishment and have not changed from the facts mentioned in the original registration, are not required to apply for a new registration. In other cases, the procedure shall be followed in accordance with a separate legislative act (1).
PERFORMANCE TO DECLARATION OF THE COMPLETE VERSION OF THE LAW
The Prime Minister is hereby authorised to declare in the Collection of Laws the full text of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws, as is apparent from subsequent amendments.
EFFECTIVE
This Law shall enter into force on 1 August 2000, with the exception of Article I (60) as regards the provisions of Article 21 (1) (e), (f) and (g), which shall take effect on 1 March 2001, and Article III (1), (2) and (3) and Article IV (4), which shall take effect on the date of their publication.
Klaus v. r.
Havel v. r.
Zeman v. r.
1) Act No. 160 / 1992 Coll., on health care in non-state health institutions, as amended by Act No. 160 / 1993 Coll.
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Regulation Information
| Citation | Act No. 149 / 2000 Coll., amending Act No. 79 / 1997 Coll., on Medicines, and on Amendments to Certain Related Acts, Act No. 20 / 1966 Coll., on the Care of People's Health, as amended, and Act No. 455 / 1991 Coll., on Business Business (Trade Act), as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 13.06.2000 |
|---|---|
| Effective from | 01.08.2000 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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