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Posts Tagged ‘medicinal products’

New Royal Decree with regards to the implementation of the Falsified Medicines Directive

May 9, 2019

Belgium

On February 8, 2019, the Belgian Official Gazette published a Royal Decree amending both the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use and the Royal Decree of 21 January 2009 concerning instructions for pharmacists.

The modifications that have been made with regards to the implementation of the Falsified Medicines Directive, include: “Without prejudice to Article 6septies, § 2 of the Act, the unique identification mark is included on the packaging of all reimbursable, non-prescription medicines whose reimbursement is not limited to delivery at the hospital.”

More information can be found here.

Safety features for medicinal products for human use – Questions and Answers – Versions 11 & 12

December 12, 2018

EU

Versions 11 & 12 of the Q&A on Safety features for medicinal products for human use have been published in October and November of 2018. Following these updates, multiple questions have been revised (1.20; 1.23; 2.21; 7.15; 8.4; 8.7) and some new questions have been added (5.8; 6.8; 8.8).

Compared to the previous version, the placing of safety features by means of stickers has been defined more in detail. Stickers must be placed under GMP conditions and the outer packaging on which the identifier is placed as a sticker must meet all applicable labelling requirements. Moreover, the use of stickers is not acceptable when the readability of compulsory regulatory information is limited.

More information can be found here.

The Dutch authorities will compensate companies for additional costs due to the Falsified Medicines Directive

December 5, 2018

The Netherlands

As a result of the Falsified Medicines Directive, companies are obliged to adapt the packaging of their medicines which leads to additional costs. These additional costs cannot always be compensated by a price increase, due to the Drug Price Act (Wet geneesmiddelenprijzen). As a pharmaceutical company, it might be challenging to maintain a reasonable profit margin in case of a low sales number and a low pharmacy price.

The Ministry of Health, Welfare and Sport in the Netherlands has therefore decided to compensate these additional costs when the following conditions are met:

  • The medicine concerned has an estimated sales volume of less than 250,000 packages in 2018, and
  • The difference between the maximum price per package and the pharmacy purchase price:
    • at an estimated volume of less than 100,000 packages in 2018: is smaller than €0.34 and €0.34 is 3% or more of the pharmacy purchase price;
    • at an estimated volume of 100,000 to 250,000 packages: is smaller than €0.12 and €0.12 is 3% or more of the pharmacy purchase price; and
  • the pharmacy purchase price is not higher than the maximum price per package.

In summary, this applies to products that are cheaper than €11.33/package (in case of a sales volume of <100,000) or cheaper than €4 (in case of a sales volume of 100,000-250,000).

Applications for compensation of these additional costs need to be submitted before 15 December 2018, 12h:

More information can be found here and in Staatscourant Nr. 60878.

New Advisory Group for borderline medicinal products

October 15, 2018

The Netherlands

An ‘Advisory Group on the Status Determination of Medicinal Products has been established in the Netherlands. This Advisory Group is composed of expert representatives from IGJ, NVWA, MEB and CCMO. The ‘Advisory Group’ advises on which legislation applies to individual products, product groups or substances at the time of assessment and given the available information, including factual information but also applicable case law and information from other countries. The advice is recorded in a database managed by the secretariat of the ‘Advisory Group’ and publicly available.  For the time being, healthcare companies remain dependent on private advice regarding market access of their products as only the listed authorities can request advice from the Advisory Group and not individual healthcare companies.

More information can be found here.

Updated Blue Box requirements

May 24, 2018

Belgium

The CMDh has updated the Blue Box requirements on 2 March 2018. Henceforth, mentioning the reimbursement category on the labeling of medicinal products is no longer required in Belgium.

Marketing authorization holders are required to remove the reimbursement category of existing products within 5 years.

The revised Blue Box requirements can be found here.

Call for verification of delivery status

January 24, 2018

FAMHP

The Federal Agency for Medicines and Health Products (FAMHP) calls on Marketing Authorization Holders (MAHs) to verify the delivery status of their medicinal products.

Prescription medicinal products are classified into following categories:

  • medicinal products on medical prescription for non-renewable delivery;
  • medicinal products on medical prescription for renewable delivery (oral contraceptives);
  • medicinal products subject to special medical prescription (psychotropic substances and narcotics);
  • medicinal products subject to “restricted” medical prescription, for example, those reserved for treatments that may only be followed in hospital environments or due to the fact that the diagnosis of the disease for which they are being used must be made in a hospital environment or because a prescription drawn up by a specialist is required.

The “restricted” medical prescription medicines are further classified into subcategories as established by the concerned industry, pharmacist associations, hospital pharmacists, nursing staff representatives, the INAMI-RIZIV, academics, and patients’ representatives. These subcategories are as follows:

  • medicinal products intended for individual medication preparation (IMP);
  • medicinal products for which delivery is reserved for hospital pharmacists;
  • medicinal products for which the first medical prescription must be made by a medical specialist and for which delivery may occur in a retail pharmacy;
  • medicinal products for which the prescription and/or administration are reserved for medical specialists and for which delivery may occur in a retail pharmacy;
  • medicinal products subject to specific legislation.

FAMHP now provides the opportunity for MAHs to verify and, if necessary, comment on the legal status of their medicines prior to publication.

More information can be found on the FAMHP website.

Medicine Shortages and Defects Notification Centre

April 14, 2017

FMEB and IGZ

On January 2nd 2017, the Medicine shortages and defects notification centre went live. The centre is coordinated by the Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ).
Via one central point, marketing authorisation holders and manufacturers can submit the following notifications:

  • A medicinal product is placed on the market for the first time, or again following an interruption
  • The marketing of a medicinal product is being discontinued or interrupted
  • A possible shortage because a medicinal product is being placed on the market in smaller quantities
  • A quality defect in relation to a medicinal product

Please keep in mind that as stipulated in Article 49 of the Dutch Medicines Act marketing authorisation holders and manufacturers are obliged to report the availability on the market and (possible) shortages of a medicinal product.