Source: https://bespokeremedy.com/pages/terms-and-conditions
Timestamp: 2019-08-24 07:13:19
Document Index: 92820221

Matched Legal Cases: ['art 14', 'art 14', 'art 6', 'art 14', 'art 5', 'art 14', 'art 14']

Terms and Conditions – Bespoke Remedy
Please use the following links to jump to specific sections in the Terms and Conditions:
Customer/Patient Declaration and MHRA
This website is operated by BespokeRemedy.com. Throughout the site, the terms “we”, “us” and “our” refer to BespokeRemedy.com. BespokeRemedy.com offers this website, including all information, tools and services available from this site to you, the user, conditioned upon your acceptance of all terms, conditions, policies and notices stated here.
Certain products or services may be available exclusively to the patients of James Barratt FBIH DHom online through the website. By supplying your personal details and agreeing to the terms and conditions you will be registered as a patient. These products or services are not over-the-counter remedies and may have limited quantities and are subject to return or exchange only according to our Return Policy.
In no case shall BespokeRemedy.com, our directors, officers, employees, affiliates, agents, contractors, interns, suppliers, service providers or licensors be liable for any injury, loss, claim, or any direct, indirect, incidental, punitive, special, or consequential damages of any kind, including, without limitation lost profits, lost revenue, lost savings, loss of data, replacement costs, or any similar damages, whether based in contract, tort (including negligence), strict liability or otherwise, arising from your use of any of the service or any products procured using the service, or for any other claim related in any way to your use of the service or any product, including, but not limited to, any errors or omissions in any content, or any loss or damage of any kind incurred as a result of the use of the service or any content (or product) posted, transmitted, or otherwise made available via the service, even if advised of their possibility. Because some states or jurisdictions do not allow the exclusion or the limitation of liability for consequential or incidental damages, in such states or jurisdictions, our liability shall be limited to the maximum extent permitted by law.
You agree to indemnify, defend and hold harmless BespokeRemedy.com and our parent, subsidiaries, affiliates, partners, officers, directors, agents, contractors, licensors, service providers, subcontractors, suppliers, interns and employees, harmless from any claim or demand, including reasonable attorneys’ fees, made by any third-party due to or arising out of your breach of these Terms of Service or the documents they incorporate by reference, or your violation of any law or the rights of a third-party.
These Terms of Service and any separate agreements whereby we provide you Services shall be governed by and construed in accordance with the laws of 104 Marsham Road, Kings Heath, Birmingham B14 5HF
Questions about the Terms of Service should be sent to us at info@BespokeRemedy.com
Customer/Patient Declaration & MHRA Advertising Statement
This website is designed to conform to the MHRA Homeopathic Medicines: Guidance on advertising **.
By placing your order you agree to the following:
“I am a patient of one of the practitioners of BespokeRemedy.com and the product I am ordering has been prescribed to me according to the terms outlined in the MHRA Homeopathic Medicines: Guidance on advertising OR I myself am a practitioner and the products I am ordering are solely for the use of myself or my patients use according to the MHRA Homeopathic Medicines: Guidance on advertising.
I indemnify BespokeRemedy.com, its practitioners, representatives and agents for and action civil or legal arising from by obtaining and or using product from them directly or via the website under false pretenses.”
**Homeopathic Medicines: Guidance on advertising
This guidance explains the legal requirements for advertising of homeopathic medicines to the public and to homeopathic practitioners and recommends best practice to ensure responsible advertising. It is supplementary to the regulatory framework in Part 14 of and schedule 32 to the Human Medicines Regulations 2012 (SI 2012/1916 – the Regulations), which implement Title VIII of European Directive 2001/83/EC.
Further information and general advice on compliance with the Regulations is available in the MHRA Blue Guide, Advertising and Promotion of medicines in the UK, available on the MHRA website.
Advertising of medicinal products has a broad definition under the Regulations and is considered to be anything which is designed to promote the prescription, supply, sale or consumption of medicinal products.
There are currently three licensing schemes for homeopathic products. Under each scheme, products must meet established standards of safety and quality but are not required to demonstrate efficacy.
_Product Licenses of Right (PLRs) were issued to all medicinal products on the market at the time that the Medicines Act 1968 was implemented in 1971. Homeopathic products covered by PLRs may include indications.
_The Simplified Registration Scheme was introduced in 1992 under Article 14(1) of European Directive 2001/83/EC. Registered products are not allowed to include indications.
_The National Rules Scheme was introduced in 2006 under article 16(2) of European Directive 2001/83/EC to regularise the inconsistencies between these two schemes. It allows homeopathic products to be granted a marketing authorisation for the relief or treatment of mild, self-limiting conditions (those that can ordinarily be relieved or treated without the supervision or intervention of a doctor).
All homeopathic products must be licensed in one of the schemes and, where possible, companies are encouraged to re-register their existing PLR products in one of the two newer Schemes.
Specific requirements for advertising homeopathic medicines to the public
Homeopathic Products with Product Licenses of Right
Schedule 32 of the Regulations provides that advertising of homeopathic products covered by product licenses of right is subject to the provisions of the Medicines (Labeling and Advertising to the Public) Regulations 1978 (SI 1978/41). These products are not covered by Part 14 of the Human Medicines Regulations 2012.
Under the 1978 regulations, the following are not acceptable:
_Promotion of a product for any disease listed in the relevant schedules to the regulations unless the specific requirements are complied with; and
_Advertising for a product which makes reference to the Advisory Board on the Registration of Homeopathic Products, the Commission on Human Medicines, the MHRA or the Licensing Authority.
Homeopathic Products registered under the Simplified Scheme
Advertising for homeopathic products granted a certificate of registration under Part 6 of the Regulations (the Simplified Scheme) is regulated under Part 14 of the Regulations. Regulation 301 governs advertising of registered homeopathic products. Only the information listed in schedule 28 to the Regulations, and included on the product labeling registered with the MHRA, , may be included in advertisements for the product. No mention of a specific indication or therapeutic claims may be made. Advice on permitted labeling is available at:
Advertising of homeopathic products granted a marketing authorisation under Part 5 and schedule 10 of the Regulations (the National Rules Scheme) is also regulated under Part 14 of the Regulations. Companies may include the homeopathic use of the product in their advertising. Promotional claims must be consistent with the authorised indication for the product and clearly state that the product is a homeopathic medicinal product used within the UK homeopathic tradition for that indication.
Other requirements for Simplified and National Rules products: All of the general rules about medicines advertising as set out in Part 14 of the Regulations apply to these homeopathic medicinal products. For ease of reference, Annex 1 provides a summary list of the other legal restrictions on advertising medicines to the public that apply to these homeopathic medicines. As for all medicines, homeopathic medicinal products should not be described in any advertising or promotional material as “essential” for a general population including people not suffering from any condition.
Homeopathic products not registered or authorised by the MHRA
1 Healthcare professional is defined in regulation 8 of the Human Medicines Regulations 2012, SI 2012/1916. Healthcare professionals are subject to statutory regulation by a body such as the General Medical Council or Health and Care Professions Council.
2 For more information on the type of healthcare professionals to whom specials may be supplied, see regulations 167 and 168 of the Human Medicines Regulations 2012.
Remedy kits advertised for specific purposes, e.g. “Childbirth Kit”, may only contain products that are licensed by the MHRA and that have indications (or usage within the homeopathic tradition for Simplified Scheme products) that are relevant to the condition. No product claims may be made for any other kit.
Advertising homeopathy services
Homeopathic practitioners may promote the service they provide for the public, e.g. the availability of a homeopathic consultation service. Details of products in any advertising must be limited to those licensed by the MHRA and must comply with the requirements set out in section 4 above.
Companies holding a ‘specials’ manufacturing licence may advertise that they make up individualised remedies to order for healthcare professionals1, e.g. “We can make to order remedies for your patients”. It should be clear that these remedies are not available for supply directly to the public.
It is only appropriate to advertise this facility to healthcare professionals who are authorised to have specials supplied to them2.
‘Specials’ manufacturers must not advertise or otherwise solicit orders for specific unlicensed products. This does not preclude them from sending out simple price lists to healthcare professionals to whom the price of specials may be relevant, such as potential customers and budget managers. Price lists can be sent out at reasonable intervals or in response to an enquiry and must not include product claims.
Registered pharmacies may also advertise that they offer a service to provide individualised remedies to the customer’s specification. In this case the customer does not have to be a healthcare professional.
Statutory requirements for advertising to the public
_the name of the product or a reasonable abbreviation thereof,
_the scientific name(s) of the stocks,
_at least one indication for use consistent with the terms in the SPC,
_a clear and legible invitation to “Always read the label” or leaflet,
Summary of other key statutory requirements
_comply with the particulars listed in the summary of product characteristics (SPC);
_encourage the rational use of the product by presenting it objectively and without exaggerating its properties;
_not be misleading.
What advertising must not include
_give the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by post, telephone or other electronic communication;
_suggest that the effects of taking the medicinal product are guaranteed, are not accompanied by side effects or are better than, or equivalent to, those of another identifiable treatment or medicinal product;
_suggest that health can be enhanced by taking the medicinal product;
_suggest that health could be affected by not taking the medicinal product;
_be directed exclusively or principally at children;
_refer to a recommendation by scientists, healthcare professionals or persons who because of their celebrity, could encourage the consumption of medicinal products;
_suggest that the medicinal product is a foodstuff, cosmetic or other consumer product;
_suggest that the safety or efficacy of the product is due to the fact that it is natural;
_be such that it might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
_refer, in improper, alarming or misleading terms, to claims of recovery;
_use, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts of it.
If after you opt-in, you change your mind, you may withdraw your consent for us to contact you, for the continued collection, use or disclosure of your information, at anytime, by contacting us at info@BespokeRemedy.com or mailing us at:
BespokeRemedy.com
104 Marsham Road, Kings Heath, Birmingham B14 5HF
If you would like to: access, correct, amend or delete any personal information we have about you, register a complaint, or simply want more information contact our Privacy Compliance Officer at info@BespokeRemedy.com or by mail at
104 Marsham Road, Kings Heath, Birmingham, B14 5HF GB
If you’ve done all of this and you still have not received your refund yet, please contact us at info@BespokeRemedy.com.
We only replace items if they are defective or damaged. If you need to exchange it for the same item, send us an email at info@BespokeRemedy.com and send your item to: 104 Marsham Road, Kings Heath, Birmingham B14 5HF
To return your product, you should mail your product to: 104 Marsham Road, Kings Heath, Birmingham B14 5HF