On January 1, 2025, new rules on extended producer responsibility for commercial packaging will enter into force. However already from April 2024, companies that market packaging or packaged products on the market, are obliged to register and report an estimate of their expected packaging quantities made available before 31 August 2024.

With the introduction of the extended producer responsibility for packaging, all companies that manufacturer, import or use packaging bear the financial and organizational responsibility for the management of packaging waste - including collection, recycling of the packaging when it becomes waste and treatment.

The rules on extended producer responsibility on packaging are based on new requirements in the EU's waste framework directive and the packaging directive, which makes producer responsibility for packaging mandatory. The overall purpose of the producer responsibility is to reduce the amount of packaging, ensure efficient collection and management of packaging waste and to motivate producers to produce better and more environmentally friendly design of packaging - both for prevention, reuse, and recycling.

All types of packaging are covered by the producer responsibility for packaging, regardless of industry, and purpose of the packaging. It is therefore  important to know the exact types of packaging, materials, and compositions used - and whether the packaging is designed to be recycled, or it is disposable.

At Tox Regulatory Advisor, we advise on all aspects of product-related legislation, including extended producer responsibility. We therefore follow developments closely so that we can help your company comply with the obligations on extended producer responsibility. For more information, please contact us at email: info@toxregulatoryaffairs.com

In January 2024, the Danish Medicines Agency launched a new national coordinated application process aimed to streamlining the authorization of combination studies in clinical trials, where a simultaneous performance study of in vitro diagnostic devices is conducted.

The Danish Medicines Agency (DKMA) in collaboration with the Danish Medical Research Ethics Committees (MREC), has introduced new guidelines on a national coordinated application process for clinical trials combined with in vitro diagnostic device performance assessments, referred to as combined studies.

Implementation of three pivotal EU Regulations consisting of the Clinical Trials Regulation (CTR), the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), which entered into force in 2021 and 2022, introduced new requirements and challenges for obtaining approval for clinical trials, clinical investigations of medical devices and performance studies.

The new requirements under CTR and IVDR can cause challenges. The challenges are specifically pronounced in clinical trials where a concurrent performance study of an in vitro diagnostic device (IVD) is conducted. To address these challenges, a national coordinated process has been established, to allow sponsors get concurrent approval from both the Danish Medicines Agency (DKMA) and the Danish Medical Research Ethics Committees (MREC). Thus, this process ensures concurrent evaluations of CTR and IVD components, allowing sponsors to concurrently update the documents in both application processes.

The national coordinated application process applies when Denmark is involved in a mono national or multinational clinical trial in the Clinical Trials Information System (CTIS). In Denmark, the competent authorities will coordinate the process between the CTIS clinical trial application (CTR application) and the performance study application (IVDR application), regardless of whether Denmark is a reporting Member State (Reference Member State, RMS) or a Member State Concerned (MSC). Differences in the timelines and how the IVDR application is coordinated depending on whether Denmark is RMS or MSC in the clinical trial in CTIS, may occur. For details on the new guideline in Danish check out: A98EE429E659440D9D713E81444B3312.ashx (laegemiddelstyrelsen.dk)

In the European market, the Cosmetic Regulation (EC) No 1223/2009 governs the release of cosmetic products and restricts the use of substances that may cause allergic reactions in consumers.

On July 26, 2023, the EU Commission published Regulation (EU) 2023/1545, amending Annex III of the Cosmetics Regulation (EC) 1223/2009 with regards to individual labelling requirements of fragrance allergens in cosmetic products.

The EU Regulation 2023/1545 amended the Annex III of the Cosmetics Regulation (EC) 1223/2009 by adding 56 new substances to the current list of 24 fragrance allergens, and these substances must be declared on labels when present in cosmetic products in concentrations exceeding 0.01% in rinse-off products and 0.001% in leave-on products.

Transitional periods

For new cosmetic products containing one of the new allergens and entering the EU market must comply with the new requirements by July 31, 2026 (within 3 years).

For cosmetic products already present on the EU market, the deadline for compliance is extended to 5 years until July 31, 2028.

For more information about fragrance allergens, please contact us at email: info@toxregulatoryaffairs.com

Attention medical cannabis professionals and manufactures of Danish made cannabis products!

On January 17, 2023, the Danish Medicines Agency released a new guideline for companies wishing to include cannabis products which are made from cannabis grown in Denmark in “the Medical Cannabis Pilot Programme”.

Brief about the medical Cannabis pilot programme:
December 15, 2017, the Danish Parliament passed the “Act on a Medical Cannabis Pilot Programme”, which came into force on January 1, 2018, and will run until December 31, 2025. The purpose of the pilot programme is to offer patients legal access to medical cannabis treatment if they have not benefited from authorized conventional medicines. Secondly, the Pilot Programme also allows cultivation and production of medical cannabis products in Denmark. Thus, companies are licensed by DMA to cultivate, produce, sell, and export medical cannabis materials and finished products. With this “Pilot Programme” medical cannabis was legalized in Denmark for dispense from a pharmacy where a physician has issued a prescription to the patient. The guideline provides, among other things, practical instructions for applications and the documentation required. For details on the  new guideline in Danish check out: https://laegemiddelstyrelsen.dk/da/nyheder/2023/ny-vejledning-til-forsoegsordningen-om-cannabisprodukter/

At Tox Regulatory Advisor we can assist you with preparation and submission of applications for cannabis intermediate products and imported cannabis primary products. 

Please contact us at info@toxregulatoryaffairs.com

Attention Medical device and IVD professionals!

January 10, 2023, the Medical Device Coordination Group (MDCG) released a new guidance on EU health institutions (in-house devices) exemption under Article 5(5) of Regulations (EU) 2017/745 medical devices Regulation, MDR) and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR).

In-house medical devices are exempted from most of the provisions of MDR and IVDR provided that the health institution adheres to the requirements laid out in Article 5(5) of the relevant Regulation.

The Guidance is relevant for healthcare professionals and researchers of health institutions who aim to design, manufacture, modify and use in-house devices.
Check out: https://lnkd.in/dFyGUPTt

ECHA has announced that by the end of 2023, summary of product characteristics (SPCs) must be prepared in. i6z file format instead of the current SPC Editor. The new format is compatible with IUCLID. Additionally, the SPC dossiers must in the future be archived in IUCLID Cloud and used for product applications in the application system R4BP 3.

To prepare for the transition, a package of supporting material is now available on ECHA´s website to help companies implement the SPC IUCLID format.
At Tox Regulatory Advisor we can assist you with preparation of your biocidal product dossiers.

Please contact us at info@toxregulatoryaffairs.com