Non-food legislation - October 2018
Pharma EU and NL
The European Commission has published new documents on the implementation of safety features under the Falsified Medicines Directive 2011/62/EU. These include a new Questions and Answers document (667 kB) and a Letter to stakeholders (221 kB). You can find more documents on the EC webpage about Falsified Medicines.
RIS World published a news item stating that “FMD regulations won’t apply after ‘no-deal’ Brexit, says MHRA”. This statement is based on a consultation published by the MHRA.
In a news item (in Dutch), the Dutch Medicines Evaluation Board (CBG) reports that manufacturers of self-care drugs have responded en masse to their call for stating the shelf life after opening on the packaging. Almost all non-prescription medicines have, or soon will have, shelf life after opening on the packaging.
Pharma USA
The US FDA has published a new Guidance document (140 kB) on the Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.
They have also updated the information about how “Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors”.
Dangerous Goods
The unique formula identifier (UFI) is mandatory for consumer mixtures from 1 January 2020, for professional use from 1 January 2021 and for industrial use from 1 January 2024. Mixtures already on the market and notified through the current procedure have a transitional period until 1 January 2025. The VIB Factory has a nice overview page about the UFI (in Dutch). ECHA has also updated the support pages with information about the obligations for dangerous mixtures.
ECHA has updated its list of hazardous substances with harmonised classification and labelling to take account of the Commission's update in the 13th adaptation to technical progress (ATP) to the CLP Regulation.
There have been some changes in regulations for the transport of dangerous goods. IMO has published a summary of the changes (32 kB) to the 2018 edition of the IMDG Code and a supplement (announcement, 2.1 MB). IATA has published some “Significant changes and amendments to the 60th edition (2019)” (112 kB) of the IATA Dangerous Goods Regulations.
On 1 January 2019, a large number of changes will again be introduced in the ADR. Traditionally, Gevaarlijke Lading publishes a white paper (in Dutch) in advance with the most important changes. This white paper can be downloaded free of charge after registration of your details.
Labelling of Cosmetic Products
ScienceDaily published an article about scientific research on the Evaluation of Labels and Ingredients of nail polish. According to the research, these labels aren't always accurate, and reformulated products aren't necessarily safer.
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