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Assessment of the product documentation on its compliance with the definition of medicinal products
The selected organisation: Zāļu valsts aģentūra
Short description:
The manufacturer of the product or his representative shall request an assessment to determine whether the product produced by it complies with the definition of the medicinal product.
Legal persons governed by public law, Private law legal persons
Within 2 months
Process description
Documents and forms
Other information
Appeal possibilities (administrative procedure)
The Ministry of Health within one month from the date of its coming into force.
The execution of the service is commenced only after a full amount of prepayment in accordance with the provisions of the BOM 17.09.2013, “Price List of Payment Services of the State Agency of Medicines”.
Laws and regulations
Farmācijas likums
(Saeima; likumi; 5/8/1997)
Zāļu reģistrēšanas kārtība
(Ministru kabinets; noteikumi; 376; 6/23/2006)
Zāļu valsts aģentūras maksas pakalpojumu cenrādis
(Ministru kabinets; noteikumi; 641; 1/1/2020)
Service classification
Service function:
Not specified
Service task:
Not specified
Inquire about the service (contact information)
Zāļu valsts aģentūra
Contact information: Adrese:  Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424, 29447659
Information about service restored: 2020.06.16.