MHRA Registration: HYPO21 has successfully passed all necessary tests and is now officially registered with the prestigious MHRA. This achievement solidifies our commitment to the highest standards of safety and efficacy.
European Recognition: In addition to MHRA, our products have also received recognition from the Spanish Agency for Medicines and Health Products (AEMPS), marking our presence and compliance in the European market.
(MD) Medical Device Status: HYPO21 is now proudly recognized as a Medical Device by MHRA, making it the first-ever PURE HOCl skin spray to achieve this remarkable status and carries MD and UKCA logos.
(CE) Marking: Alongside its MHRA registration, HYPO21 carries the CE marking, signifying conformity with European Union regulations and standards.
Understanding the Importance of MHRA:
The Medicines and Healthcare Products Regulatory Agency (MHRA) plays a pivotal role in safeguarding public health. It is the UK regulatory body responsible for ensuring that medicines, medical devices, and blood components meet the required standards of safety, quality, and efficacy. MHRA's rigorous evaluation process involves assessing products to guarantee they meet the highest standards before they are made available to the public.
Why MHRA Matters:
Consumer Safety: MHRA's oversight ensures that only safe and effective products reach consumers, providing peace of mind to those who use HYPO21.
Regulatory Compliance: Registration with MHRA demonstrates our commitment to complying with the strict regulatory standards set by this esteemed agency.
Product Efficacy: MHRA's recognition of HYPO21 as a Medical Device signifies its efficacy in promoting skin health and well-being.
Regulation (EC) No 1223/2009 defines a cosmetic product as "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours". HYPO21 Purifying Skin Spray is a FIRST EVER COSMETICALLY LICENSED PURE HOCL skincare solution due to the purity of it's formulation. HYPO21 was first granted UKCP and CPNP Licence in 2021.
HYPO21 has received approval and certification from the prestigious Vegan Society for our product, HYPO21. This recognition is a testament to our unwavering commitment to providing vegan-friendly options to our valued customers.
Vegan Society Certified: HYPO21 has undergone rigorous evaluation and has met the strict criteria set by the Vegan Society, a leading authority in promoting vegan principles.
Licensed and Certified: Our commitment to transparency and authenticity is further validated by obtaining the necessary licenses and certifications.
HYPO21 is pleased to have obtained the revised standard ISO 9001 : 2015. ISO 9001 is the international standard that defines the requirements for a Quality Management System (QMS). A Quality Management System enables organisations to manage their processes and systems in order that customer and other stakeholder requirements can be achieved. At its core is the principle of continuous improvement.
ISO aims to ensure that products and services are safe, reliable and of good quality. Whilst ISO certification does not guarantee product quality it does ensure that the processes that surround the product are controlled and performed in a consistent manner.
HYPO21 is pleased to have obtained the revised standard ISO 14001:2015. ISO 14001
ISO 14001 is an internationally agreed and recognised standard for Environmental Management Systems. An EMS supports organisations in identifying, managing, monitoring and controlling environmental processes.
ISO 14001 calls on organisations to proactively manage their environmental impact through a commitment to pollution prevention, legal compliance, and continual improvement. Environmental Management System certification to the ISO 14001 standard helps organisations demonstrate an ongoing commitment to improving environmental performance.
It is an offence to test a finished cosmetic product or an ingredient on an animal in order that the product may comply with the requirements of Regulation (EC) No 1223/2009.
The Regulation also restricts the supply of cosmetic products whose final formulation, or any ingredient or combination of ingredients, have been tested on animals. HYPO21 is 100% Vegan and Cruelty Free and has never been tested on animals. We do use Certified Cruelty Free Labs for all our testing and certifications.