DOC’s will need to be submitted for new Class I IVD ARTG registrations
The online event was part of the 3rd edition of the international conference Biotech Atelier 2020
Subject matter experts from PharmaLex Bulgaria have recently organized an online webinar session dedicated to the wonder substance cannabis from a medical perspective. The event was part of the European biotechnology conference – Biotech Atelier 2020 that brings together recognized scientists, business leaders, international experts in the field of Biotechnology, Healthcare, Life Sciences, Pharma and Information, and Computer Technologies.
During the session “Medicinal Cannabis: The Wonder Substance”, experts discussed the potential of the medical substance, as well as the way it is produced, regulated, registered, and distributed.
Albena Eftenova, Managing Director of PharmaLex Bulgaria, opened the session by explaining that in the European Union there is no set law on cannabis or of its medical use. Every country has its own regulatory requirements with regards to production, cultivation, and distribution.
Barbara Siebertz, PhD, Senior Manager, Regulatory Affairs & Special Projects, PharmaLex Germany was the first speaker at the event. She gave an overview of the European legal basis and regulatory requirements for cannabis, and the variety of medical conditions proved to be used for.
“Medicinal cannabis is a new business in most countries and its highly volatile status leads to uncertainties within authorities. The business presents a high potential for all stakeholders and will lead to increasing CTAs and MMAs in mid-term perspective” – she said.
The second speaker of the event was Ute Hegener, Director, Quality Management & Compliance, Head of Regulatory Affairs Team, PharmaLex. In her presentation, she focused on the complex pharma regulations in specific European countries that entrepreneurs need to be compliant with.
According to her, new entrepreneurs who are not familiar with the pharma business often struggle in the early phase and need better guidance. PharmaLex provides support by clarifying the legal situation in the current market and resulting obligations for the company and the anticipated products.
The final presenter was Bosilka Kocare, Senior Specialist Regulatory Affairs, PharmaLex. She addressed the situation in North Macedonia as playing an important role in the cannabis industry. She also explained that the cultivation of cannabis for medicinal purposes has been permitted by law in North Macedonia in March 2016.
“The cannabis industry will grow rapidly by 2025, with an estimated value of tens of billion dollars worldwide. This is one of the reasons why many companies invest in this industry in North Macedonia” – she commented.
If you would like to learn more details about the topic, you can watch the full Youtube Video here: https://bit.ly/38Jcze3
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