Regulations on the sale of drugs for non-medical use


Date FOR 1983-03-01-628


Ministry of Health and Care Services


Published In 1983 195


Commencement 01/03/1983

Edited
FOR 2013-02-14-199

Changes


For
Norway

Legal

LOV-1992-12-04-132-§16 LOV-1992-12-04-132-§22, LAW-1992-12-04-132-§23

Promulgated


Short Title
Regulations on sales of drugs (non-med.)

Adopted by Ministry of Social Affairs (now the Ministry of Health) on 1 March 1983 the Act of 20 June 1964 No.. 5 about drugs with further amended by the Act of 3 June 1977 no. 53, § 6 second paragraph, ref. Royal Decree. of 5 August 1977 and 26 November 1982 and §§ 20 and 21, ref. Royal Decree. of 16 December 1977.
Added authority: Act 4 December 1992 No.. 132 on medicines etc. § 16, § 22 and § 23 (added as a result of dep.gjennomgangen 97/98).
Changes: Amended by regulations 27 Dec 2000 no. 1577, February 14, 2013 No.. 199.

§ 1. Definition. Scope With drugs for non-medical use is defined in this regulation drugs, including drugs, technical, scientific and other non-medical uses. This regulation does not drugs that are prohibited, cf. § 4 of the regulations on narcotics by 30 June 1978.

§ 2. Sales of drugs for non-medical use right to sell drugs for non-medical use has Norwegian Medicinal, chemists and others who have received the Norwegian Medicines Agency permission.

§ 3. Purchase of drugs for non-medical use right to purchase of drugs for non-medical use has

A)
those who have the right to sell the same drug, cf. § 2;

B)
managers of public and publicly approved laboratories, scientific and educational institutions. When buying drugs must Norwegian Medicines Agency's permission exist;

C)
doctors, dentists and veterinarians laboratory use and veterinarians to killing of animals;

D)
enterprises, institutions or people over 18 years who have received special permission from the Norwegian Medicines Agency.

For non-prescription medicines are not required separate purchase authorization.

§ 4. identification, requisition etc. Seller shall ensure that the buyer has the right to buy drugs for non-medical use. Bids must be over 16 and show authority. The buyer is unknown to the seller, the buyer shall show legitimajson.
When purchasing prescription drugs, including drugs to buy the permit is submitted to the seller. Buyers who do not need special permission from the Norwegian Medicines Agency shall instead submit a written requisition signed by the person entitled to purchase. The requisition must contain information about what medicine should be used.
Requisition or purchase a permit to be kept by the seller in one year. The document relates to drugs, should be kept by the seller for 3 years. If drug accounts appears to § 15 of the regulations on narcotics by 30 June 1978.

§ 5. Packaging Agents for non-medical use must only comes in strong, full and sealed containers. Do not use bottles or other containers because of its regular use can lead to dangerous confusion.

§ 6. Marking Preparations for non-medical use, when issued the following marking, or both external and internal packaging:

1.
Invented trade name and the INN name. If INN names are not set used BAN-name electric or drug designation by usual chemical nomenclature. When selling complex composition shall nature and quantity of the drugs indicated.

2.
Name and address of the person who has manufactured or packaged goods or introduced item in packed condition.

3.
General warning text:

"For non-medical use. Keep out of reach of children, away from food and nytelselsmidler and feedstuffs. "

4.
Additional Warning:

A)
Drugs listed in the Substances, ref. § 5 of the regulations on labeling, sale etc. of chemical substances and products that can endanger your health on 26 November 1982 shall be marked in accordance with the provisions there.

B)
Drugs should have married noticed and marked: "Toxic if swallowed."

Other prescription medicines should be labeled: "Can cause poisoning if swallowed."
By labeling of drugs (including drugs) that can be absorbed through the skin or by inhalation additional warning added ".... (if swallowed) inhalation or skin contact. "

5.
Other warnings.

Drugs with special properties that can endanger your health should be applied separately warning text, for example. "May cause allergic reactions," "May cause cancer", "Irritant", "Corrosive". This does not apply to drugs as indicated by section. 4a).
The warning label shall be clearly and stand out from other text, etc. on the packaging.


§ 7. Storage. Use Drugs for non-medical use should be kept safe, ref. § 6 no. 3 a).
Drug and other prescription medicines should be kept in locked cabinets, etc
Preparations for non-medical use should be kept in the packaging they are handed in from the seller.
Preparations for non-medical use only for the purpose they are delivered to and are not disclosed to unauthorized people.

§ 8. Exceptions Norwegian Medicines Agency may grant exemptions from these regulations.

§ 9. Entry into force. Transitional provision This regulation comes into force immediately. The labeling provisions in § 6 shall be completed by 1 March 1984.