Translated using Hugo.lv
Opinion on the compliance of a customs warehouse with the requirements for the storage of medicinal products in line with the guidelines for good distribution of medicinal products published by the European Commission.
Selected Organization: Veselības inspekcija
Brief description:
The Health Inspectorate shall, at the request (application) of the customs warehousing holder (owner), inspect the storage site of the medicinal product and provide an opinion to the customs warehouse keeper (owner) regarding the conformity thereof with the requirements of good distribution practices specified in the guidelines for good distribution of medicinal products published by the European Commission.
Beneficiaries:
Private law legal persons
Maximum period (in working days):
22
Period:
Upon receipt of the request of the customs warehousing keeper (owner) and the necessary documents, the Health Inspectorate official shall check the compliance of the warehouse with the requirements for storage of medicinal products within 30 days and shall provide an opinion to the customs warehousing keeper (owner) regarding its compliance with the requirements of good distribution practices specified in the guidelines for good distribution of medicinal products published by the European Commission.
Process description
Other information
1. solis / Service requests
The client shall submit an application to the Health Inspectorate, accompanied by certified document derivatives:
1.1. Authorisation for the holding of a customs warehouse;
1.2. A customs warehousing plan (plan scheme) with a designated storage room for medicinal products;
1.3. Internal regulatory enactment regarding the receipt, dispatch, ensuring storage conditions in conformity with the specification of medicinal products, the conditions specified by the manufacturer and the accounting in the customs warehouse (quality system document), ensuring the storage of medicinal products in a safe place separate from other goods;
1.3.1. If the storage of narcotic drugs and psychotropic medicinal products is provided for in a customs warehouse, the procedures for the storage of narcotic drugs and psychotropic medicinal products shall be specified in the internal regulatory enactment in conformity with the requirements
1.4. An order for the responsible person (responsible persons);
1.5. A document attesting the verification and calibration of equipment or equipment used for temperature and environmental control;
1.6. Document attesting the maintenance of the pest programme (Agreement on Disinfectant, Disinsectisation and Deratisation Services).

The service is free.
Payments: View payments
An e-service in authorities home page Veselības inspekcijas e-adrese
On the spot The head office in Riga region VI
Adrese: Klijānu iela 7, Rīga, LV-1012
Tālrunis: 67081600
Fakss:
Other contact details:
E-mail vi@vi.gov.lv
Mail The central office in Riga region
Adrese: Klijānu iela 7, Rīga, LV-1012
Tālrunis: 67081600
Fakss:
Other contact details:
By phone 67357811
2. solis / Receipt of services
A customs warehouse in which medicinal products are intended to be stored must have an opinion of the Health Inspectorate regarding the compliance of the warehouse with the requirements for the storage of medicinal products in accordance with guidelines for good distribution of medicinal products published by the European Commission (available in the official language on the website of the State Agency of Medicines).

The Health Inspectorate shall, at the request of the customs warehousing holder (owner), inspect the storage site of the medicinal product and provide an opinion to the customs warehouse holder (owner) regarding its compliance with the requirements of good distribution practice guidelines for medicinal products published by the European Commission.

Upon written request of the customs owner (submitted with a secure electronic signature, submitted in paper format or in the portal www. latvija.lv - Application for the Health Inspectorate), the Health Inspectorate shall perform the inspection and draw up a control act.

Where a customs warehouse has been found to comply with the requirements of good distribution practices laid down in the guidelines for good distribution of medicinal products published by the European Commission, the Health Inspectorate shall draw up an opinion in paper format and send the customs warehousing holder to the address indicated in the request.

The holder (owner) of the referred to opinion shall submit the referred to opinion to the Food and Veterinary Service in accordance with the regulatory enactments regarding the operation of customs warehouses.
Payments: View payments
More information in national language

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