During the pre consortium stage, members jointly develop the consortium budget which will be approved in the consortium agreement.

It is difficult to estimate the total cost for each company due to several factors, including:

• The cost for each substance depends on the laboratory fees for data generation (if any).
• If a company already possesses relevant data to share, the final cost might be lower, as compensation costs will be reimbursed.
• While the pre-consortium will start with at least three participating companies, additional companies may join (pre-)consortium later, which would reduce costs by spreading them across more members of the consortium.
• The number of data required for given substance is under discussion in pre-consortium and therefore it is not known at an early stage what is going to have to be paid.

Given these uncertainties, it is not possible to provide a precise estimate. However, to get an idea of a cost estimate you may consider reviewing similar data generation costs incurred by companies in the past and assume that the costs will be split between, e.g. five, companies.

If a company is interested in joining a (pre-)consortium as a Late Joiner, it should contact either AESGP at consortia@aesgp.eu or the respective AESGP Project Manager (if known). In turn, further information, depending on the stage of the work, will be provided.

Initially, each company joining the pre-consortium will be invoiced 1,500 EUR to start the work – cost of immediate collaboration.

For non-AESGP members, a management cost of 3,000 EUR will be invoiced in addition to 1,500 EUR.

Additional funds may be invoiced to all involved parties during the pre-consortium phase, following the formal acceptance of the budget, to cover the costs of an external consultant for literature search, data quality validations, or any other possible external costs.

The incentives for consortium members to join, share their own data within the consortium or generate new data include fostering enhanced collaboration and gaining access to resources, which can lead to improved research outcomes. Sharing or generating data also enables members to reduce costs, as expenses are divided fairly among the consortium members, ensuring a more efficient use of resources. Additionally, members can leverage the consortium’s collective expertise to fulfil regulatory requirements and advance their research objectives.

Late Joiners can be admitted to the (pre-)consortium after it has been formed, as long as they meet the necessary membership requirements. Membership remains open for the duration of the (pre-)consortium, provided new members make a fair financial contribution to the costs that have already been incurred.

Consultants cannot directly join AESGP Consortia as members. Membership is open only to legal entities that meet the Consortium Membership Criteria (see question above).

Eligible consortium members must meet the Consortium Membership Criteria that will be specified in the Memorandum of Understanding and/or Consortium Agreement.

In general, these criteria will be that consortium members must be at all times:

• a legal entity validly incorporated; and
• a market operator having, throughout the term of the consortium, a vested interest in maintaining the use of the respective ingredient for which the consortium is created, including for example manufacturers, importers, distributors and sellers of consumer healthcare products containing the ingredient as well as manufacturers, importers, distributors and sellers of the ingredient itself.

A pre-consortium brings companies together to identify data gaps and lay the groundwork for forming a consortium. The pre-consortium is governed by the Memorandum of Understanding that frames the cooperation in that phase before a consortium is established.

Once established, the consortium enables members to collaborate in collecting, sharing, and generating information on a specific ingredient. The consortium is governed by the Consortium Agreement.

AESGP’s consortium framework allows interested companies to work together on specific ingredient-related topics, within the consumer self care sector, in a structured and legally compliant way. Consortia are typically set up to prepare, generate, or share information needed to support regulatory requirements, such as risk assessments.

Consortia managed by AESGP are self funded by their members. Membership is open throughout the life of the consortium, meaning companies can join later if they make a fair contribution to the costs already incurred.

The consortium framework allows companies to pool resources, avoid duplication of effort, share the financial burden and work collectively on shared regulatory challenges, while keeping the scope of cooperation clearly defined.

The platform covers 200 non-prescription medicine APIs. You can view the full list here.

AESGP applies GDPR-compliant measures, including restricted access to authorized staff, encryption, and organizational safeguards. Participants agree to Terms & Conditions and Privacy Policy, which prohibit unauthorized access, hacking, or sharing sensitive data. AESGP also monitors for breaches and safeguards the fair use of the platform.

For technical issues, contact AESGP at matchmaking@aesgp.eu. For privacy-related questions, reach out to the Data Protection Officer at dpo@aesgp.eu.

No, the platform does not currently offer an export function. All data is accessible online through the secure interface.

Data is updated every time a new company joins the platform or upon request from a participating company to reflect changes in ERA data ownership or interest.

Access is open to all pharmaceutical companies with a vested interest in OTC Active Pharmaceutical Ingredients (APIs) covered by the API list. Each company has one account and nominates a Matchmaking Contact person for platform interactions.

The AESGP databanks do not store specific information on products or manufacturers; they only contain the regulatory framework for specific countries.

For assistance, please contact info@aesgp.eu.

We don’t offer trial period / trial access to the AESGP Data Banks. Detailed information on the content of each AESGP data bank can be found on their respective pages.

Information presented in the databases is based on data provided mainly by AESGP and GSCF member associations. It is reviewed and updated annually.

No, it is not. Upon expiration of your access, you will receive a reminder email inviting you to renew or cancel your subscription.

The subscription is for a period of 12 months (independent the starting date). After this period, you will receive a reminder email inviting you to renew or cancel your subscription.

For more information on partnership fees, please contact us.

You can apply for partnership if you offer, or could offer, services to AESGP or its members in the areas such as advertising, PR, regulatory affairs, marketing, sales and distribution, etc. and if you commit to AESGP mission.

Companies wishing to apply for partnership shall apply in writing to AESGP giving the following information:

• A letter stating that the company wants to join AESGP
• The letter shall be addressed to AESGP President
• The letter shall state your company’s objectives, in particular in the area of self-care

The application will be reviewed by the AESGP board at their next meeting.

For more information on membership fees, please contact us.

If you are not eligible for Full Membership, you can apply to be an Associate Member if you are:

• A national association located in Europe and representing self-care medical devices and/or food supplements, unless one of those categories is already represented by a Full Member.
• A manufacturer of proprietary non-prescription medicines and/or food supplements and/or self-care medical devices in Europe, and are in membership of national associations that are Full or Associate Members in all the countries in which they are present.

You can apply to be a Full Member if you are:

• A national association located in Europe and representing consumer healthcare products manufacturers. Only one association per country is allowed.
• A manufacturer of proprietary non-prescription medicines that meets the following requirements:
  • You are present in a majority of European countries by placing your products on the market,
  • and you are in the membership of all the national associations in Full Membership of AESGP in those countries where you are present. Presence on the market is understood as having an affiliate active in a country.

Associations or companies wishing to apply for Full or Associate membership shall apply in writing to AESGP giving the following information:

• A letter stating that the association/company wants to join AESGP
• The letter shall be addressed to AESGP President
• If you are a company, it is advisable to state your company’s objectives, in particular in the area of self-care, as well as to mention its brand portfolio.
• If you are a national association, it is advisable to state your objectives and the estimated number of members

The application will be reviewed by the AESGP board at their next meeting.

Regulation 2017/745 is applicable since May 2021. Since that date, all medical devices, including self-care medical devices, must comply with the provisions of the Regulation. However, subject to certain conditions, transitional periods allow medical devices with a certificate obtained under the previous legislative framework to be placed on the market at the latest until December 2027 or 2028, depending on the risk class of the given device.

Apart from general changes that affect all types of medical devices, such as improved transparency through a comprehensive EU database on medical devices and a device traceability system based on unique device identification or strengthening of post-market surveillance requirements for manufacturers, Regulation 2017/745 expressly recognizes substance-based medical devices. In particular, classification rule 21 addresses specifically medical devices composed of substances or of combinations of substances.

The main difference between self-care medical devices and (non-prescription) medicines concerns the mode of action. Self-care medical devices achieve their principal intended action by chemico-physical means whereas (non-prescription) medicines act by pharmacological, immunological or metabolic means.