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The State Council Regulation On The Control Of Narcotic Drugs

Original Language Title: Valtioneuvoston asetus huumausaineiden valvonnasta

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State Council Regulation on drug control

See the copyright notice Conditions of use .

In accordance with the decision of the Council of State, which has been presented by the Ministry of Social Affairs and Health, the drug law of 30 May 2008 (3703/2008) Pursuant to:

ARTICLE 1
Scope

This Regulation lays down a drug law (3703/2008) Shall be subject to authorisation, subject to authorisation and supervision.

ARTICLE 2
Quotas

Every year, the Agency shall submit to the International Narcotics Control Board for the purpose of establishing quotas the following year estimates for medical and scientific research for the following year: The quantities of substances in List I and II of the Single Convention.

Where the granting of an import authorisation would result in the quota being exceeded, an additional assessment should be made to the International Narcotics Control Board for the purpose of establishing a new quota. The authorisation shall not be granted until the new quota is fixed.

ARTICLE 3
Import and export licences

The import and export licence of the drug shall mention the name and possible international name of the drug, the quantity of the drug in question, the name and address of the importer and the consignor or of the exporter and the consignee, the time limit within which: Import or export is to be carried out, as well as the conditions imposed pursuant to Article 13 (2) and Article 14 (3) of the Law on Narcotic Drugs. The export licence shall also indicate the number and date of the import authorisation and the authority which issued it.

In addition, if the substance is imported or exported, the certificate shall indicate the name of the product, if there exists, and the pharmaceutical form.

In the case of the import and export of drugs, the customs authority shall indicate the number of the consignment note or invoice number, the signature of the customs official, the name clarification, the date and the invoice number of the consignment or export licence issued by the Medicines Agency. Stamp of the customs office.

The authorisation holder shall return, in addition to the certificate, a copy of the licence or invoice accompanying the certificate.

§ 4
Conditions attached to the import authorisation and return of documents

Import licences shall be accompanied by a condition that imports into Finland from customs warehousing are prohibited. For specific reasons, the condition may not be included in the import authorisation for drugs included in List I of the Convention on Psychotropic Substances, in which case the authorisation shall be expressly authorised for import into the customs warehouse.

Where the substance required for import authorisation has been imported or the period prescribed for importation has expired, the medicinal product shall return to the competent authority of the exporting country a copy of the export authorisation bearing the date of import, and Of the quantity of drugs imported.

§ 5
Identification of the drug coating

The substance shall indicate the name of the substance as indicated in the lists of the 1961 Single Convention or the Convention on Psychotropic Substances. In addition, the substance or preparation of the substance or preparation shall be shown on the substance of the drug intended for sale.

ARTICLE 6
Storage and storage of drugs

The pharmaceutical company and the pharmaceutical wholesale market shall not contain more than the substance necessary for the normal use or sale taking into account the prevailing market conditions.

Preparations containing substances in List III and IV of the Convention on Psychotropic Substances shall be stored in a place where bystanders have been prevented as effectively as possible.

§ 7
Disposal of drugs

A Protocol on the eradication of substances and preparations belonging to the lists I, II and IV of the 1961 Single Convention on Narcotic Drugs and the Convention on Psychotropic Substances shall be drawn up, indicating the name, quantity and Batch number. The minutes are signed by two persons, one of whom must be the responsible person. Disposal shall be entered in the records of the drugs records and the minutes shall be attached to the accounting records.

§ 8
Pharmacy accounts

The pharmacy shall keep records of substances and preparations listed in the lists I, II and IV of the 1961 Single Convention on Narcotic Drugs and the Convention on Psychotropic Substances.

The following information shall be shown in the drug accounting records:

1) the name of the drug or preparation;

(2) the amount of the purchase, the date of acquisition and the acquisition date;

(3) the quantity, the date and the recipient of the stock, or the patient;

(4) the quantity of stock;

(5) the name of the doctor who ordered the medicine;

(6) the number of the logbook or batch of fabrics; and

(7) the initials and date of the person making the entries.

§ 9
Accounting for hospitals and health centres

The hospital pharmacy and the Centre shall keep records of the substances and preparations listed in the lists of I-IV and the Convention on Psychotropic Substances in the 1961 Single Convention on Narcotic Drugs. The accounting records shall show the same information as provided for in Article 8 (2). Instead of the patient and the name of the doctor, the accounts shall be entered in the title or unit of activity to which the drug or preparation has been supplied.

Where a medical pharmacy or a medical centre is supplied to the department or any other action unit or pharmacy to submit a written medical order for the 1961 Single Convention on Narcotic Drugs (lI) and IV or Psychotropic Substances, The substance or preparation of List I III of the Convention should be accompanied by a specific consumer card. The consumer card shall include the name, quantity, date of delivery and the name of the department or unit of operation. The name of the patient, the dose, the doctor's name and the person's signature and date of the medicinal product used as a medicinal product should be entered.

After exhaustion of the product, the consumer card shall be returned to the hospital pharmacy, the medical centre or the pharmacist, signed by the department or the competent medical doctor.

ARTICLE 10
Accounting for pharmaceutical wholesalers and pharmaceuticals

The pharmaceutical wholesale trade and the pharmaceutical company shall keep records of the substances and preparations listed in the lists of I-IV and the Convention on Psychotropic Substances in the 1961 Single Convention on Narcotic Drugs. The pharmaceutical plant must also keep a record of the substances contained in the list of substances in List IV of the Convention on Psychotropic Substances, which shall indicate the quantities of drugs used in the manufacture. The accounting obligation of the pharmaceutical company also applies to preparations containing psychotropic substances which are exempted from authorisation.

Drug accounting for pharmaceutical wholesalers and pharmaceutical companies must show the following information:

1) the name of the drug or preparation;

(2) the quantity and the purchase order entered into storage;

(3) the quantity and location of the warehouse;

(4) the quantity of storage; and

(5) the initials and date of the person making the changes.

In addition, the pharmaceutical plant must keep records of the quantities produced and the losses in the manufacturing process.

ARTICLE 11
Accounting of authorities and marketing authorisation holders

The authorities which have the right to hold a supply of drugs and the holder of the drug processing authorisation shall keep a narcotic record as well as the pharmaceutical wholesale trade provided for in Article 10. However, instead of a consignment, indicate the intended use.

The Protocol on drugs seized by the Authority shall be regarded as accounting for the purposes of paragraph 1.

ARTICLE 12
Accounting for importers and exporters of drugs

The entry and export of drugs shall keep records of the substances listed in the lists I-IV of the 1961 Single Convention on Narcotic Drugs and the Convention on Psychotropic Substances. The accounts shall also indicate the quantities of drugs included in preparations for which import or export is exempted from authorisation.

The accounts of importers and exporters of drugs shall show the following information:

1) the name and quantity of the substance;

(2) where exports or imports from countries have taken place;

(3) the date of import and export; and

4) the number of import or export authorisations.

The records shall indicate the customs marking of the amount of the drug and other customs markings on the date.

ARTICLE 13
Accounting of veterinary surgeons

Veterinarians shall keep records of the substances and preparations listed in the lists of I-IV and the Convention on Psychotropic Substances in the 1961 Single Convention on Narcotic Drugs.

Drug records for veterinary surgeons should show the following information:

1) the name of the drug or preparation;

(2) the quantity and date entered into storage or storage;

(3) the quantity of storage; and

4) a description of the drug used or disposed of.

ARTICLE 14
Entry into force

This Regulation shall enter into force on 1 September 2008.