Please note that the Regulation of the Cabinet of Ministers No. 641 “Price List of Paid Services of the State Agency of Medicines” (hereinafter – Price list) was adopted on 10 December 2019 and lays down Agency’s services, procedure for payment and concessions. The Price list came into force on 1 January 2020.
Please see further text for the main information included in the Price list.
Updated on 7 February 2020 (with one sentence): In which cases the Agency, by default, will not apply the annual post authorisation maintenance fee?
By default, the Agency shall apply a reduction of 100% of the annual post-authorisation maintenance fee in the following cases:
- The turnover of a medicinal product distributed in Latvia and authorised via the national, mutual recognition or decentralised procedure does not exceed 3000 euros (excluding VAT) in the previous calendar year; or
- The number of packagings sold for a medicinal product distributed in Latvia and authorised via the national, mutual recognition or decentralised procedure does not exceed 49 packagings. Updated information regarding medicinal products authorised and distributed in Latvia is recorded on 1 January of each year.
The Agency does not apply a reduction of 100% of the annual post-authorisation maintenance fee if the medicinal product has not been distributed in Latvia during the previous calendar year.
The annual post-authorisation maintenance fee will be applied, based on turnover data submitted by medicinal product wholesalers regarding the previous year. The annual fee will not be applied on the first year of marketing authorisation or renewal.
From now on, you do not need to submit to the Agency a request to waive the annual post authorisation maintenance fee.
Is there no fee for variations to marketing authorisation documentation in accordance with the new Price list?
In order to decrease costs to clients and facilitate administration of payments, the cost of expertise related to variations to marketing authorisation documentation has been included in the annual post-authorisation maintenance fee (Paragraph 5 of the Annex to Price list).
In which cases should the annual post-authorisation maintenance fee be paid?
The fee must be paid once a year in the calendar year following the adoption of decision regarding marketing authorisation or renewal of medicinal product according to an invoice issued by the Agency in compliance with data from the Medicinal Product Register of Latvia that is updated on 1 January of each year.
Can the payment be divided into several instalments?
Yes. Marketing authorisation holders may divide payments into several instalments for invoices covering 30 medicinal products or more. The payment may be divided in up to 4 payments to be paid within the calendar year.
What new paid services have been included in the Price list?
- Annual maintenance fee for parallel imported medicinal products (Paragraph 13 of the Annex to the Price list)
This new service will decrease the administrative burden on parallel importers because by paying an annual fee they will no longer have to pay for each variation to the permit for parallel import of a medicinal product.
The annual maintenance fee for parallel imported medicinal products must be paid once a year according to an invoice issued by the Agency in compliance with data from the Medicinal Product Register of Latvia and the register of pharmaceutical activity companies that is updated on 1 January of each year.
- Annual fee for maintenance of documentation and information for general-type pharmacy (Paragraph 27 of the Annex to the Price list)
An annual fee has been applied to all of the services provided by the Agency to pharmacies and pharmacy branches to ensure maintenance of updated documentation and information at the Agency.
A general-type pharmacy must pay an annual fee for maintenance of documentation and information once a year according to an invoice issued by the Agency in compliance with data from the Medicinal Product Register of Latvia and the register of pharmaceutical activity companies that is updated on 1 January of each year.
In order to facilitate pharmaceutical care outside of city territory, as well as to broaden consumer options by expanding medicinal product availability, the Agency shall apply a 100% discount to the annual fee for document and information maintenance for a general type pharmacy, if one of the following requirements is fulfilled:
- For a merchant who has received no more than two special permits (licences) for pharmaceutical activity and the turnover did not exceed 300 000 euros (excluding VAT) in the previous calendar year; or
- For a general-type pharmacy outside towns with a turnover that did not exceed 300 000 euros (excluding VAT) in the previous calendar year.
You do not need to submit a request to the Agency to waive the annual fee, as it will be applied, based national statistic reports.
Please note:
The annual fee for maintenance of documentation and information for general-type pharmacy will not be applied on the year of issuance of special authorisation (licence).
The fee for service will not be applied for evaluation of documentation of closed-type pharmacies.
- Annual fee for maintenance of documentation and information for medicinal product wholesaler (Paragraph 28 of the Annex to the Price list)
The medicinal product wholesaler must pay an annual fee for maintenance of documentation and information once a year according to an invoice issued by the Agency in compliance with data from the Medicinal Product Register of Latvia and the register of pharmaceutical activity companies that is updated on 1 January of each year.
Please note:
The annual fee for maintenance of documentation and information for medicinal product wholesalers will not be applied on the year of issuance of special authorisation (licence).
- Annual fee for maintenance of documentation and information for pharmaceutical activity of a company registered in a EU member state or EEA country for wholesale distribution, manufacturing or import of medicinal products (Paragraph 31 of Annex to the Price list)
- Scientific advice (Section 8 of the Annex to the Price list)
Scientific advice is a paid service provided by the Agency upon request from a current or potential marketing authorisation holder only outside of an ongoing procedure for marketing authorisation, renewal or variations.
Scientific advice may be provided regarding the choice of procedure or legal framework for marketing authorisation of a medicinal product, regarding quality of medicinal product, non clinical and clinical research and issues related to pharmacovigilance. Advice may be provided at any stage of medicinal product development or post-authorisation. A request for a scientific advice must be submitted beforehand in writing, indicating the questions to be reviewed.
Please note:
The Agency will continue to provide consultations on regulatory issues (for example, what kind of documents must be submitted, how to group variations, how to add a unique identifier and a packaging seal to a specific medicinal product) for free.
- Determining electrical conduction (Sub-Paragraph 48.27 of the Annex to the Price list)
- Determining other solvents (Sub-Paragraph 48.28 of the Annex to the Price list)
- Quantitative and qualitative analysis of pharmacy’s extemporaneous preparation (Section 54 of the Annex to the Price list)
In accordance with the Regulations Regarding the Procedures for the Manufacture and Control of Medicinal Products, the Requirements for the Qualification and Professional Experience of a Qualified Person and the Procedures for the Issuance of the Certificate of Good Manufacturing Practice to a Medicinal Products Manufacturing Undertaking, the State Agency of Medicines performs full chemical testing – qualitative and quantitative analysis – of medicinal product samples submitted for expertise. This service will be applied to medicinal product samples selected at random as part of an inspection by the Health Inspectorate, as well as samples submitted to the laboratory for such analysis by other physical or legal persons.
- Expertise on application and documentation for use of list I, II and III narcotic, psychotropic substances and precursors controlled in Latvia in manufacturing (Paragraph 26 of the Annex to the Price list)
- Compliance evaluation or compliance surveillance inspection of an establishment for utilisation of tissues, cells in a country not within the EEA (Sub-Paragraph 39.8 of the Annex to the Price list)
- Expertise on application and documentation for direct distribution of specific tissues and cells from an establishment for tissue and cell procurement (including import and export) to healthcare institutions for immediate transplant in an identified recipient (Paragraph 41 of the Annex to the Price list)
- Expertise on application and documentation for emergency import or export of tissues or cells (for tissue establishments or healthcare institutions) (Paragraph 42 of the Annex to the Price list)
On 1 January 2020, the new Regulation shall replace the regulation of the Cabinet of Ministers No. 873 of 17 September 2013 “Price List of Paid Services of the State Agency of Medicines”.
Please see full text of the new Price list on Agency’s website: section “Legislation” > “Paid Service Price list”.
The Annotation of this Regulation in Latvian is available here.
Please forward any other questions regarding implementation of the new Pricelist to info@zva.gov.lv. Please note that your question and the answer will be published anonymously.
