Translated using machine translation service Hugo.lv
Insert the list of products covered by the amount of medicinal products
The selected organisation: Nacionālais veselības dienests
Short description:
The list of products covered by the amount of the country. Decision making regarding medicinal products or medical devices included / excluded in the list on the basis of the applicant's submission.
Beneficiaries:
Private law legal persons
The medicinal product registration certificate holder (owner) or his authorised representative, a wholesaler of medicinal products or his authorised representative or the State Agency of Medicines for the importation of non-registered medicinal products of the authorisation holder or his authorised
Maximum duration (days):
120
Process description
Documents and forms
Other information
1. solis / Application submission
The application submission services requested.

An application for placing medicinal products in the amount of medicinal products. The information you want to add to the submission:
- Summary of clinical trials in accordance with the requirements laid down in national health service and copy of publications (if you submit a submission of a new common name / general name combinations for inclusion in the list of reimbursable medicinal products).
- Expected compensation of the funds allocated to the calculation of consumption, including the comparative therapy, target groups of patients and the number of patients, as well as the calculation of possible procedures of reimbursement of the medicinal products to be sold in Latvia and the estimated turnover (euro).
- pharmaco-economic calculations (according to the economic assessment guidelines, if he or she submits the application of a new common name / general name combinations to be included.
- Information on the sales price of the manufacturer in the country of manufacture and the European Union Member States, indicating the price in the currency of the relevant country and the euro.
- Attestation for the permanent provision of reimbursable medicinal products on the market.
- Pilnvara, if the medicinal product registration certificate shall be deposited with the owner (holder) authorised representatives.
- Document, which certifies the registration in the applicant in one of the European Economic Area countries, as well as representation certificate of authority (copies).

The application of medical devices of the Medical Devices list. The information you want to add to the submission:
- Expected compensation of the funds allocated to the calculation of consumption, including the comparative therapy, target groups of patients and the number of patients, as well as the calculation of possible procedures of reimbursement of medical devices sold in Latvia in amount and the estimated turnover (euro).
- a copy of the EC declaration of conformity and package leaflet in English with the CE conformity marking.
- Information on the sales price of the manufacturer of medical devices in the country of manufacture and the European Union Member States, indicating the price in the currency of the relevant country and the euro.
- Attestation for permanent reimbursable medical equipment market.
- Pilnvara if documents shall be submitted to the medical device registration certificate holder (holders) authorised representatives.
- Document, which certifies the registration in the applicant in one of the European Economic Area countries, as well as representation certificate of authority (copies).

The application of medicinal products or medical devices for the revision of the basic price of reimbursement. The information you want to add to the submission:
- The justification for the calculation of the ex-works price of the basic price of reimbursement or replacement. Justification for raising the basic price of reimbursement may be an increase in production costs, exchange rate changes, the maximum the wholesaler's mark-up is applied.
- Anticipated compensation of the funds allocated to the calculation of consumption at basic price of reimbursement changes, including the comparative therapy, target groups of patients and the number of patients, as well as the calculation of possible procedures of reimbursement of medicines and medical devices sold in Latvia in the quantity and the estimated turnover.
- For information on medicinal products or medical devices on the sales price of the manufacturer in the respective currency and euro exchange rate set by the Bank of Latvia in accordance with the application submission day in all those Member States of the European Union where the relevant medicinal products or medical devices are sold.
Documents to be submitted
Payments: View payments
On the spot The Central Office
Adrese: Cēsu iela 31 k-3, Rīga, LV-1012
Phone number:
Fakss:
Other contact details: 6. ieeja. 2. stāvs, 249. kabinets
Working time
2. solis / Receipt of services
Receipt of services according to the application of choice.
Payments: View payments
On the spot The Central Office
Adrese: Cēsu iela 31 k-3, Rīga, LV-1012
Phone number:
Fakss:
Other contact details: 6. ieeja. 2. stāvs, 249. kabinets
Working time
Mail The Central Office
Adrese: Cēsu iela 31 k-3, Rīga, LV-1012
Phone number:
Fakss:
Other contact details: 6. ieeja, 4. stāvs

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