Publication date: November 14, 2024
Article 45 paragraph 2 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 (OJ EU L. of 2002 No. 31, p. 1, as amended) in addition to the type of information included in the scope of labelling also specifies the media on which this information is provided. It includes both information media that are physically connected with the foodstuff (packaging, label, jacket, leaflet, tag, attached documents) and documents related to the product, but not necessarily directly attached to it (e.g. commercial documents, product specifications transferred in the course of trade between entrepreneurs). Such a broad scope of labelling differs from the traditionally understood labelling of goods, which covers only the information placed on the product itself, its packaging or label. Therefore, product labelling means any action, connection of a given information medium, e.g. a label with a product or service, as a result of which a physical connection is established between the specific medium and the product”. [1]
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Publication date: November 13, 2024
New labelling requirements for medical cannabis as pharmaceutical raw material
Introduction
On 1 July 2024, a new European Pharmacopoeia monograph, Cannabis flos (3028), entered into force. This involves introducing changes to the registration dossiers for pharmaceutical raw materials based on hemp other than fibrous hemp.
Legal basis
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Publication date: November 07, 2024
EU AND POLISH PERSPECTIVE
The role of Polish Agency for Health Technology Assessment and related reimbursement of medicinal products
1. Introduction
In December 2021, Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ EU L 458, 2021, p. 1; hereinafter referred to as the Joint Clinical Assessment Regulation or the Regulation) was adopted. In turn, less than half a year ago, Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 was adopted, establishing, in accordance with Regulation (EU) 2021/2282 on health technology assessment, procedural rules on interactions during the preparation and updating of joint clinical assessments, the exchange of information on the preparation and updating of joint clinical assessments and the participation in the preparation and updating at Union level of joint clinical assessments for medicinal products for human use, and establishing document templates for those joint clinical assessments (OJ EU L 2024; hereinafter referred to as the Implementing Regulation).
Both of these regulations will soon become legally binding, which will lead to fundamental changes in the pharmaceutical market of the European Union Member States, including Poland. A joint clinical assessment will be introduced, as a result of which the clinical assessment of medicines and medical devices introduced to the Polish market will no longer be carried out at the national administration level by the Agency for Health Technology Assessment and Tariff System.
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Publication date: October 29, 2024, BY Zaid Adnan Jaber
Cultural and religious challenges for medicinal drugs registration in Islamic countries. An overview of the market size of the Islamic countries
The Islamic-compliant pharmaceutical market has been emerging significantly. According to the Salaam Gateway report on Halal pharma, Muslims spent around $108 billion in 2022, and this amount is expected to increase to $142 billion by 2027. This growth has led many Southeast Asian and European pharmaceutical companies to form agreements and collaborations with countries like Saudi Arabia and Indonesia. For example, Indonesian pharmaceutical companies have engaged in joint investments with China totaling $120 million, in addition to cooperation with South Korea.
The Middle East and Africa (MEA) market has reached a value of $32.6 billion, with Saudi Arabia being the largest market at $11.6 billion and experiencing a growth rate of 9.1% per year, making it the third fastest-growing country in the MEA region. The UAE ranks as the third-largest market, valued at $4.1 billion, and has seen a growth rate of 16.5% per year, making it the second fastest-growing country in the region.
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Publication date: October 28, 2024
With the current medical standards, the birth of a new medicinal product (drug) can only become a fact as part of a long and expensive research and development process. Such a process is burdened with a high risk of failure. Usually, the research and development process lasts many years and is low in efficiency. However, such research is undoubtedly needed.
How to obtain permission for a clinical trial of a medicinal product?
In order to obtain permission to conduct such a trial in the territory of the Republic of Poland, an application for permission must first be submitted. Such an application may be submitted only by the sponsor – which stands for a natural person, company, institution or organization responsible for initiating, managing and arranging the financing of a clinical trial (Article 2, paragraph 2, point 14 of the Regulation of the European Parliament and of the Council (EU) No 536/2014 of 16 April 2014, OJ EU.L.2014.158.1). The sponsor is obliged to submit such an application via CTIS (i.e. the new European system, Clinical Trials Information System) to each interested Member State concerned by a given clinical trial. In the case of the Republic of Poland, the body that issues permits for clinical trials is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
CTIS Account
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