The ALLTUB Group has expertise in regulatory compliance.
Our in-house team of pharmacists, in collaboration with external consultants, follow the evolution of regulations to make sure that the products delivered to customers comply with the regulations in force in the countries they are marketed. They also ensure that the products are safe for end-users’ health in accordance with the various regulations in force.
The ALLTUB Group complies with the European Regulation REACH and CLP in force since June 1st, 2017 (Regulation (EC) n°1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Regulation (EC) n°1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation)).
The ALLTUB Group also complies with the European Regulation 994/2013 relating to the SVHC (REACH and the previous legislation, Directive 76/769/EEC). ALLTUB also possesses DMFs for the United States and Canada (Drug master Files type III (FDA), Drug master files type III (Health Canada)).
All our products comply with the general European Directive 94/62/EC relating to legal obligations in terms of packaging and packaging waste. The objectives as defined in the Directive are the following:
- Reducing waste at source,
- Waste identification and recovery: all states must implement a system of waste return, collection and recovery.
These are all the directives related to our business sector:
- Directive 2004/12/EC,
- Directive 2005/20/EC (longer application deadlines for new member states),
- Decision of the commission 97/129/EC (it defines the non-mandatory symbols to identify materials in order to facilitate their collection, re-use and recovery including recycling).