Frequently asked questions
What search results can I obtain by clicking on the magnifying glass next to the name of active substance?
You can select all medicinal products with the same active substance.
What do the symbols – green tick and red cross – mean with regard to medicinal product availability?
The green tick indicates that the medicinal product is available at wholesalers, but the red cross indicates that the medicinal product is not available at wholesalers.
How to select medicinal products according to custom criteria?
In order to select medicinal products according to custom criteria, select the appropriate criteria in the “Additional parameters” section.
Additional parameters for searching the Register are conveniently grouped together. For example, you can choose to select either prescription or over the counter medicinal products, or view only medicinal products included in the List of Reimbursable Medicinal Products (KZS) or KZS reference or cheapest medicinal products in the equivalent medicinal product group.
Additional information includes recommendations regarding medicinal product use in patients above the age of 75 and in sports. The Register also includes information (special symbol) whether the relevant medicinal product is approved for use in children (until the age of 18).
You can also combine several criteria to select medicinal products in the Register. For example, you can select all medicinal products approved for use in children, as well as all of the reimbursed medicinal products approved for use in children.
Does the Register allow you to view complete information regarding a specific medicinal product?
The Register allows you to instantly view complete information about a specific medicinal product. For example, package leaflet and permitted maximum price at pharmacies.
In addition, the Register allows you to select medicinal products according to the parameters selected in the “Additional parameters” section.
Information included as additional parameters will only be included if you have selected the relevant search parameter. In other cases, the information will not be displayed next to the medicinal product. For example, if you wish to select only medicinal products approved for use in children then the information will be displayed only if you have selected the relevant additional search parameter.
What is the permitted maximum price at a pharmacy?
The price of medicinal product may be different at a pharmacy, but it may not exceed the permitted maximum price at a pharmacy indicated in the Register. In case of any doubts regarding the basis for medicinal product pricing or a price exceeding the maximum, please report to the Health Inspectorate!
Can I select only medicinal product with a “declared price”? And what does “declared price” mean?
One of the new features of the Register is the option to select the criteria “Show only medicines with a declared price”. This means that distribution of this packaging of a medicinal product has been initiated and/or is continued in Latvia.
Marketing authorisation holders have to inform the Agency regarding the price of a specific medicinal product prior to start of distribution. For example, if the medicinal product is authorised, but is not yet distributed in Latvia, the permitted maximum price of this medicinal product at the pharmacy will not appear in the Register, even though the Register shows all the authorised medicinal products, including products not distributed in Latvia for various reasons.
What are the three sections in the initial Register window?
The initial Register window has three separate sections:
- Diagnoses and medications – this section allows you to view disease groups and ATC (Anatomical Therapeutic Chemical) code of medications. Searching by an ATC code allows you to select medicinal products included in specific groups of medicinal products. For example, you can find a list of medications intended for treatment of respiratory diseases.
- NHS List of state reimbursed medicines – this section allows you to select only medicinal products included in the List of Reimbursable Medicinal Products.
- Meds 75+ - this section contains information regarding use of active substances in elderly persons and includes classification of almost 500 active substances or their combinations and recommendations for their use in persons above the age of 75. Names of active substances are divided into categories (A, B, C and D) depending on how appropriate is their use in persons above the age of 75. The description of each active substance also includes information regarding the most notable risks and warnings, as well as the most frequent adverse reactions and interactions.
When is it important to note the symbols “KZS L1 – L5”?
If there is a symbol “KZS R” or “KZS L” next to the name of the medicinal product in the Register, but the product is not available at wholesaler level (i.e., there is a red cross “X” next to the name of the product), then the pharmacy should dispense the next cheapest state reimbursed medicinal product – the product with the symbol “KZS L1” – in exchange for a special prescription issued by a doctor indicating the name of the active substance. However, if the medicinal product with the symbol “KZS R”, “KZS L” or “KZS L1” is not available, then the next cheapest available medicinal product included in the List of Reimbursable Medicinal Products and denoted with the symbol “KZS L2” should be dispensed (the number in the symbol indicates order – first to fifth cheapest medicinal product).
Why can’t I find a medicinal product in the Register?
There may be several reasons why a medicinal product can’t be found in the Register:
- Medicinal product has been authorised in Latvia a couple of days ago via the mutual recognition, decentralised or national procedure or via the centralised European marketing authorisation procedure, but the data has not been updated on the State Agency of Medicines’ database or on the website of European Medicines Agency (EMA);
- Marketing authorisation of medicinal product has been suspended due to public health or safety concerns, and distribution of medicinal product is prohibited;
- Medicinal product has been withdrawn from Medicinal Product Register upon request from the marketing authorisation holder and the time for distribution of remaining stock (6 months) has elapsed;
- Medicinal product has been withdrawn from Medicinal Product Register due to expiration of marketing authorisation and the time for distribution of remaining stock (6 months) has elapsed.
Why are medicinal products withdrawn from the Register?
Medicinal products may be withdrawn from the Register for two reasons:
- Upon request from the marketing authorisation holder;
- In accordance with the regulations on registration on medicinal products (in Latvian) if the marketing authorisation holder has not submitted documentation for renewal and the marketing authorisation has expired.
Who is responsible for the availability of medicinal products?
In accordance with the normative acts, the marketing authorisation holder or its authorised representative is responsible for placing medicinal products on the market, as well as provision of information to the Agency regarding initiation of medicinal product distribution or potential disruptions in the availability of medicinal products.
Why is a medicinal product unavailable?
The most frequent reasons for disruptions in the supply of medicinal products reported by marketing authorisation holders are related to issues with medicinal product manufacturing, increasing demand for medicinal products, logistical issues and serialisation. Or wholesalers have ran out of stock.
How can I submit a report regarding unavailability of a medicinal product?
The Agency has prepared a convenient online tool – an electronic form “Report disruptions in the supply of medicinal products” for residents, pharmacies, healthcare institutions and marketing authorisation holders or their authorised representatives to report disruptions in the supply of medicinal products to the Agency.
What determines the price of a medicinal product?
The price of a medicinal product is determined by the manufacturer. In accordance with the requirements for medicinal product manufacturers laid down by the normative acts, the manufacturer’s wholesale price for the medicinal product must be declared at the Agency upon initiation of distribution of medicinal product and the manufacturer must inform regarding changes to the price in a timely manner. The State Agency of Medicines calculates the maximum price allowed for sale at pharmacies, according to the requirements of normative acts.
Please note that the price of medicinal products included in the list of reimbursable medicinal products is determined by other principles applied by the National Health Service.
Why is the price of medicinal products different in other countries?
It has to be noted that the medicinal product manufacturer is entitled to determine varying prices for their medicinal products in different countries and each country has a different VAT, as well as mark up applied to the price.
Why do some medicinal products in the Register have an attached document “Opinion on therapeutic effectiveness and cost-effectiveness of medicinal product”?
The Agency prepares opinions regarding the therapeutic and cost-effectiveness of medicinal products upon request (application) from the marketing authorisation holder when the marketing authorisation holder intends to submit an application to the National Health Service in order to:
- Include in the List of Reimbursable Medicinal Products a medicinal product with a non-proprietary name that has not been included before;
- Change/expand conditions for reimbursement for a medicinal product already included in the List of Reimbursable Medicinal Products, including other diagnoses, other patient groups, etc.
What does the statement “Stock may be distributed until” next to the packaging mean?
If the marketing authorisation holder submits a variation to marketing authorisation documentation, as a result of which one of the current medicinal product packagings will no longer be manufactured, the State Agency of Medicines will, after approval of such variation to the marketing authorisation documentation, add a corresponding remark in the Medicinal Product Register informing that the current packaging may be distributed until a certain time.
What kind of information may be received by selecting the additional search parameter “Information on usage in sports”?
By selecting this additional search parameter, you can find out whether the medicinal product may or may not be used in sports and whether there are any specific conditions for their use in sports (there will be a “Yes” in the column “Information on usage in sports” with more information indicated below).
The Medicinal Product Register includes information only regarding substances and medicinal products prohibited from use in sports and included in the List of Prohibited Substances and Methods created by the World Anti-Doping Agency (WADA). The Medicinal Product Register includes information only regarding the medicinal products available for purchase in Latvia. The Medicinal Product Register does not include information regarding nutritional supplements.
The Medicinal Product Register indicates whether the use of medicinal product is prohibited during competitions or outside of competitions. It also provides more information regarding limitations to their usage in sports.
The information included in the Medicinal Product Register regarding usage in sports is only informative in nature and may not be considered as authorised information regarding the status of the substance or method in sports.
The Anti-Doping Bureau of Latvia provides updated and accurate information as much as possible, but shall not take responsibility regarding errors or inaccuracies.
Please note that in special circumstances or situations a consultation from a doctor or pharmacist may be necessary. Please note that changes to the list of prohibited substances and methods, as well as information regarding new medicinal products is updated after inclusion of medicinal product in the Medicinal Product Register or after publication of the list on the website of the World Anti Doping Agency: World Anti-Doping Agency > What is Prohibited.
How often is the data on the Medicinal Product Register updated?
The data on the Medicinal Product Register is updated every day.
Last update on 2024-04-25 04:38:33
