Report on medicine shortage

This form is not intended to notify competent authorities of the withdrawal of a marketing authorisation or a change in the marketing status of any particular product.

1You are filing the report as a..

2 Product details

Product name*:

Place where the medicine was not available - name of pharmacy, address*:

Pharmacy name*:

Address:

License no.:

Details on shortage

Date of the beginning of shortage (may be anticipated date)*:

Expected end date of the shortage, if applicable*:

Reason for shortage*: Impacted countries (if known): Reference number of any Rapid Alert (quality/safety) related to the issue: Other authorities notified (e.g. other NCAs, EMA), including reference to Quality Defect report if relevant: Reference to related pending regulatory action, if relevant: Risk assesment of impact of shortage*: Proposed mitigation plan to deal with the shortage: Are any actions from NCA required? If yes, what actions?:

3Details of notifying person

Your contact information, phone and/or e-mail address*:

Your contact details will be used only in case additional information will be required.

Company name and address (MAH, duly authorised representative or wholesale distributor, if applicable):

Name of the person completing the form*:

Telephone number contact person: E-mail of contact person*:

Your contact details will be used only in case additional information will be required.

4Impact assesment

Potential alternative medicinal products

Same medicine in different packaging size/strength/pharmaceutical form: Other medicinal product with the same active substance: Authorised and marketed products in the same class (therapeutic/pharmacological subgroup) with the same indications: Authorised and marketed products in other class with the same approved indications:

Possible supply of foreign packaging*: Yes No

ATTENTION! By 31 December 2022, medicinal products for which no substitutes are available on the Latvian market have simplified procedure for distribution in foreign country packaging. More information on the procedure for the distribution of medicinal products in foreign country packaging: www.zva.gov.lv » Foreign country packaging in Latvia

Estimated size of population affected by the shortage of this product

Market share of the product (hospital and ambulatory markets)*: Market sales volumes (monthly/six monthly) and volume of prescriptions: Proportion market sales affected by shortage: Estimated stock in the current supply chain: Stock that will be made available at the expected end date of the shortage and at the following supplies:

Fields marked with * are required.

Notes

Statement of the State Agency of Medicines regarding processing of personal data