05/12/2023
Gentelmen/ Members of the Chamber
Greetings,
Asharqia Chamber extends its warmest greetings and informs you of receiving a letter from the Saudi Chambers Union, number (45102280), dated (19/5/1445H). Referring to the letter from the General Authority for Food and Drug Administration, number (14043/A), dated (15/5/1445H), regarding the potential occurrence of serious medication errors due to the improper use of pharmaceuticals from the therapeutic group (Vinca Alkaloids).
Therefore, companies owning the marketing rights for pharmaceutical products containing the mentioned therapeutic group are required to comply with the following:
1. Add a clear warning in English on both the outer and inner packaging of the product as follows: "FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES."
2. Update the Summaries of Product Characteristics (SPC) for the products to include:
Guidance to healthcare practitioners in the "Section" on using infusion minibags instead of syringes to avoid the risk of intrathecal administration.
Addition of the sentence in Section 4.2: "To reduce the potential for fatal medication errors due to incorrect route of administration, [Product Name] injection should be diluted in a flexible plastic container and prominently labeled as indicated – 'FOR INTRAVENOUS USE ONLY FATAL IF GIVEN BY OTHER ROUTES.'"
Emphasize the necessity of using the products by intravenous injection and warn against injecting the products into the spinal cord in Sections 4.2, 4.3, and 4.4.
3.Update Section 2.3 in the Patient Information Leaflet (PIL) to emphasize the need for intravenous injection and warn against injecting the products into the spinal cord.
Compliance with the above requirements is required by July 2024, and it is mandatory for products submitted for registration and those applying for registration licenses to adhere to this directive.
Sincerely
