Suspected quality defects in medical products

Holders of an authorisation under Article 40 of Directive 2001/83/EC and under Article 44 of Directive 2001/82/EC (i.e. manufacturers and importers of medicinal products) are obliged under Article 13 of Directive 2003/94/EC or Article 13 of Directive 91/412/EEC and GMP Guide Chapter 8.8 to report to their Competent Authority any defect in a medicinal product handled under their authorisation that could result in a recall or abnormal restriction in supply. This includes possibly faulty manufacture, product deterioration, detection of falsified medicines or any other serious quality problems with a product. It is normally the Qualified Person who has this responsibility.

This obligation of the holder of manufacturing licence is stipulated by points 7 and 10 of the Article 27 of the Law on Pharmacy of the Republic of Lithuania as well as by point 49 of the Oder No V-268 of the Minister of Health of the Republic of Lithuania of 23 April 2004 „Regarding confirmation of provisions of Good Manufacturing Practice of medicinal and investigational medicinal products (Order)(Ministry of Health of the Republic of Lithuania/V-523/2004-04-23/Came into force since 27 July 2005/Official Gazette, 2005, No. 90-3381)

For your convenience there is a unified form for such report. Report about suspected quality defects in medicinal product may be submitted to the Agency using following means:

In writing (by arriving to the Agency, sending report by post or through courier),

By fax (+370-5) 263 98 95 and/or (+370-5) 263 92 65;

By e-mail: vvkt vvkt.lt

Report about suspected quality defects in medicinal product (as well as in investigational medicinal product or counterfeited medicinal products) may be submitted in a free form in writing or by phone during working hours (+370-5) 263 98 91, (+370-5) 263 98 94 and (+370-5) 263 62 94, in urgent cases – after office hours and on non-working days by phone (+370-677 92316).  A free form reports at least the following information should be indicated:

Data of a sender of a report (first and last names, position, represented legal entity, address, telephone number, fax number, e-mail address);

Data about medicinal product with suspected quality defect (name, strength, pharmaceutical form, package size and type, package language, batch number, expiry date, number of marketing authorisation or number of registration certificate, marketing authorisation holder);

Data about suspected quality defects in medicinal product (when, where, on what conditions a defect was detected, description of non-compliance, relationship of quality defect with undesirable reaction, what quantity of medicinal product has been distributed, through what distributors and to what consignees (if known), what actions regarding medicinal product with suspected quality defect had been taken before submitting a report to the Agency, what actions are foreseen, other information that a sender of a report would consider as important).

Suspected quality defect in medicinal product (quality defect) – is present or expected deviation of medicinal product from the terms to marketing authorisation of a medicinal product.

Handling of reports of suspected quality defects in medicinal products and Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects are harmonized procedures and included into Compilation of Community Procedures on Inspections and Exchange of Information. Competent Authorities of the EU to follow this compilation are obliged by provisions of Article 3 of the directive 2003/94/EB, in Lithuania such obligation is legitimated by point 3, Article 61 of the Law on Pharmacy.

During examination of suspected quality defects in medicinal products and during classification according to the risk to public health it is necessary to follow Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects, Appendix 1 ,,Rapid Alert System: Classification of Urgency of Defective Medicinal Product Alerts“ of the Compilation of Community Procedures on Inspections and Exchange of Information taking into account classes of quality defects as well to follow quality risk management principles of the good manufacturing practice (Appendix 20). If a recall is being considered extremely important issues to consider include:

- possibility of an out-of stock situation;

- availability of alternative products;

- clinical effect to a patient of a disruption in supply.

Reports about suspected quality defects in medicinal products which are submitted to the Agency are processed and co-ordinated by the Inspectorate for Pharmaceutical Companies.

Manufacturing authorisation holder is obliged to submit to the Agency all necessary information related to quality defect and quality defect analysis conclusions based on the principles of classification of quality defects and principles of quality risk management.

Conclusions of investigation of quality defect are submitted to manufacturers or marketing authorisation holders by the Agency in writing.

Information about recalled medicinal products may also be found on the webpage of the Agency under the section „Control of Pharmaceutical Activity“, „Medicinal products recalled from the market“.