Mutual recognition

The Connectivity Standards Alliance and the Cyber Security Agency of Singapore Sign Mutual Recognition Arrangement on Cybersecurity Labels for Consumer IoT

Retrieved on:

Martedì, Marzo 19, 2024

Cyber Security Agency, Mutual recognition, Certification, CSA, Connectivity Standards Alliance, MRA, Medical device

DAVIS, Calif., March 18, 2024 /PRNewswire/ -- The Connectivity Standards Alliance (Alliance) and the Cyber Security Agency of Singapore (CSA) have marked a significant milestone by signing a Mutual Recognition Arrangement (MRA), solidifying their dedication to recognizing their respective cybersecurity labels for consumer Internet-of-Things (IoT) devices.

Key Points:

DAVIS, Calif., March 18, 2024 /PRNewswire/ -- The Connectivity Standards Alliance (Alliance) and the Cyber Security Agency of Singapore (CSA) have marked a significant milestone by signing a Mutual Recognition Arrangement (MRA), solidifying their dedication to recognizing their respective cybersecurity labels for consumer Internet-of-Things (IoT) devices.
This MRA is the outcome of collaborative discussions aimed at fostering global cooperation, advancing the harmonization of standards, reducing duplicate testing procedures and costs for manufacturers, and improving security for consumer IoT across geographic boundaries.
Such harmonisation in cybersecurity requirements and mutual recognition will provide greater incentives to manufacturers to incorporate Cybersecurity-by-Design and Cybersecurity-by-Default into their IoT devices."
The agreement between the Alliance and CSA signifies a landmark commitment to cultivating international cooperation and coordination in cybersecurity.

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on:

Domenica, Marzo 10, 2024

Well, DER, Fungus, Capsule, TUR, Interest, Animal, Part, Exercise, Database, Viral, Hepatitis, Powder, Collection, Directive, Union, Nutrient, DSM-IV codes, Volume, CTD, Legislation, Literature, Fermentation, Diabetes, Pharmacopoeia, Inhalation, Committee, Monograph, NTA, WEU, DCP, AIDS, See, Mineral, Marketing, Safety, Plant, MRA, Autoimmunity, Directive 2001/83/EC, GMP, Documentation, Seed, Heart failure, Distillation, CHMP, MRP, European Medicines Agency, Guideline, Disorder, Mutual, Convention, State, Tablet, Community, Clinical trial, Rapporteur, European Commission, Woman, Medication package insert, Vitamin, Quality, Authority, GACP, SAWP, Pharmacovigilance, Civil service commission, HMPS, Science, Health, Bibliography, Section 4, Infection, Kampo, Commission, Abbreviation, Pathology, Prescription, Human, Medication, Reproduction, EMA, NCA, Chapter One, EDQM, TAM, European Pharmacopoeia, European Economic Area, Food, Regulation (European Union), COM, TCM, Administration, Mutual recognition, Procedure, Medicine, Herbal, Answer, Q&A, HIV, EudraLex, Cancer, Public, Medicinal plants

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Key Points:

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Committee on Herbal Medicinal Products (HMPC)
Questions & Answers on the European Union framework
for (traditional) herbal medicinal products, including those
from a ?non-European? tradition

Table of Content
1.
European Pharmacopoeia
SAWP

Scientific Advice Working Party

SmPC

Summary of Product Characteristics

THMP

Traditional Herbal Medicinal Product

TUR

Traditional Use Registration

WEU

Well-Established Use

Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Terminology of herbal medicinal products (Q&A 1-4)
Question 1
What are herbal substances, herbal preparations, and herbal medicinal products?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 4
Are food supplements regulated under the European Union (EU) pharmaceutical legislation
for (traditional) herbal medicinal products ((T)HMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Regulation of herbal medicinal products in the European Union (Q&A 511)
Question 5
Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
products (HMPs), including traditional herbal medicinal products (THMPs), in the European
Union (EU)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
These countries have,
through the EEA agreement, adopted the complete Union acquis on medicinal products and are
consequently parties to the Union procedures.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Specific provisions for traditional herbal medicinal products (Q&A 1221)
Question 12
Which indications can be granted for traditional herbal medicinal products (THMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Nov. 2023
Answer 17
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 29
Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
(registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
Discussion with Member States intended to be
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.

Carbon Streaming Provides Corporate Update and Announces New Removals Streaming Agreement With Mast Reforestation

Retrieved on:

Venerdì, Febbraio 9, 2024

Carbon, Forestry, Amendment, Ministry, MOEF, Climate change mitigation, Water quality, World Bank, Farmer, MRA, Nalgonda, SRN, AWD, Dixie Fire, Mutual recognition, Environment

TORONTO, Feb. 09, 2024 (GLOBE NEWSWIRE) -- Carbon Streaming Corporation (Cboe CA: NETZ) (OTCQB: OFSTF) (FSE: M2Q) (“Carbon Streaming” or the “Company”) is pleased to provide a corporate update including announcing that it has entered into a streaming agreement with Mast Reforestation SPV I, LLC (“Mast”), for the Baccala Ranch project (the “Baccala Ranch Reforestation Project”) in California, USA (the “Baccala Ranch Reforestation Stream”). The Baccala Ranch Reforestation Stream is the third stream under its previously announced project pipeline streaming agreement with Mast, to advance its pipeline of post-wildfire reforestation projects in the Western USA.

Key Points:

The Baccala Ranch Reforestation Stream is the third stream under its previously announced project pipeline streaming agreement with Mast, to advance its pipeline of post-wildfire reforestation projects in the Western USA.
The Baccala Ranch Reforestation Project is expected to remove a total of approximately 91,500 tCO2e and generate an equivalent number of carbon credits.
Carbon Streaming will also make ongoing delivery payments to Mast for each carbon credit sold under the Baccala Ranch Reforestation Stream, which will increase according to a tiered streaming structure dependent on return on invested capital thresholds.
The Company has entered into an amendment to its Sheep Creek Reforestation streaming agreement to reflect these updates.

Grace Breeding Provides Summary Update on Progress Related to its Leading Programs for the First Half of the Year

Retrieved on:

Lunedì, Agosto 14, 2023

REHOVOT, Israel, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Grace Breeding Ltd. (the "Company" or "Grace Breeding") (TASE: GRAC), a forward-thinking AgClimateTech company developing sustainable biological-based products to improve crop yield and vigor, today announced summary update of developments related to its two lead product candidates for the first half of 2023.

Key Points:

“This first half of the year has been one filled with equal momentum for both of our lead programs.
This represents the Company’s first product registration approval for its WDS in the European Union (EU) and facilitates Grace Breeding’s registration process in other EU countries.
The field trial was conducted by Eurofins Group, a global leader in contract research services, as well as development collaborator, Gaia AgroSolutions.
Specifically, the field trials showed that yields were increased while using half the amount of synthetic nitrogen fertilizer containing urea.

Grace Breeding’s NFT Bio-Fertilizer Receives its First European Product Registration Approval in Austria for Use in Wheat and Corn

Retrieved on:

Giovedì, Giugno 29, 2023

NFT, Urea, Food safety, Czech Republic, Farmer, BAES, Mutual recognition, Carbon, Nitrogen fixation, TASE, European, Environment, Fertilizer, EU

REHOVOT, Israel, June 29, 2023 (GLOBE NEWSWIRE) -- Grace Breeding Ltd. (the "Company" or "Grace Breeding") (TASE: GRAC), a forward-thinking AgClimateTech company developing sustainable biological-based products to improve crop yield and vigor, today announced that it received product registration approval in Austria by the Austrian Federal Office for Food Safety (BAES) for its innovative NFT bio-fertilizer, to be marketed as a “soil improver” product, for use in wheat and corn under the brand name “Addir™.” This represents the Company’s first product registration approval in the European Union (EU) and enables Grace Breeding to obtain rapid Mutual Recognition registrations in other EU countries, including Belgium, the Czech Republic, Germany, Greece, Portugal, Slovakia, and Spain.

Key Points:

“We are extremely proud to receive our first product registration for our proprietary bio-fertilizer, Addir, in Europe, which comes not long after our initial product registration in Brazil last month,” said Assaf Dotan, CEO of Grace Breeding.
“In Hebrew, ‘Addir’ means ‘strong one’, which is a testament to how our product works as a bio-fertilizer to grow hearty plants and to strengthen root systems and other parts of the plant.
However, our natural fertilizer does so by relying on less amounts of urea, the byproducts of which are harmful to the environment.
The use of a bio-fertilizer like Addir, which makes use of nitrogen fixation, leads to reduced use of urea and consequently lower carbon emissions, which is crucial for slowing damage to the environment.