1.	Constitution
1.1	The European Pharmaceutical Aerosol Group (hereafter ‘EPAG’) is a voluntary non-profit making consortium of member companies.
1.2	Member companies should comply with the membership criteria (1.18) and be approved for acceptance by EPAG members.
1.3	All member companies must strive to meet the EPAG objectives (see 2). The EPAG objectives and constitution can be altered by the approval of EPAG members (see 1.19).
1.4	A nominated person, selected by that company, will represent that member company. Usually, only one person will be regarded as the full time company representative, and will act in all respects of liaison. A substitution can be made in place of the nominated person.
1.5	As the need arises, additional company staff may attend EPAG meetings, workshops, sub-teams etc.
1.6	EPAG will have a chairperson and Organisational Team. EPAG members will elect the chairperson by a majority vote of members. The chairperson will be elected for a period of 2 years. After this time a new election will be held, for which all members are eligible.
1.7	Members can call for a vote of confidence in the chairperson at any time, if a majority vote of member companies support ‘no confidence’ the chairperson will be removed and a new election held, for which all members are eligible.
1.8	The Organisational Team (hereafter OT) will be elected for a period of two years. After this time a new election will be held, for which all members are eligible.
1.9	The OT will be responsible for the following:
1.9.1	Organise the time of the meetings, contents and agenda.
1.9.2	Ensure EPAG membership is fully informed of all appropriate information
1.9.3	Communicate with external persons, organisations, on behalf of EPAG.
1.10	Member companies, on a voluntary basis, will host meetings, but rotation to each company is expected.
1.11	The individual companies will meet costs associated with attending EPAG meetings.
1.12	Meetings will have an agenda and can be chaired by a nominated person, other than the EPAG chairperson, if authorised by the chairperson.
1.13	Meetings will be called at the discretion of the OT, members can request meetings to the OT.
1.14	At the beginning of each meeting a member will be asked to volunteer to provide minutes and action notes of each meeting. These will be approved by the OT and then circulated to all members.
1.15	EPAG members will lead particular meeting agenda items, they will ensure these are documented, that any responsibilities are agreed and that any follow-up actions completed by the responsible person. As appropriate they, or a delegated person, will feed back at a further EPAG meeting.
1.16	Within EPAG, sub-teams may be set-up to consider specific topics. A sub-team leader will be elected from the EPAG company representatives.
1.17	Decision making
1.17.1	Decisions will normally be made on a consensus basis (i.e. everyone agrees to the decision).
1.17.2	Where it is impossible to reach a consensus, a decision will be made by a majority vote, companies that cannot support the decision will be recognised in the documentation.
1.17.3	Each member company has one vote.
1.18	Membership
1.18.1	Companies may apply to EPAG for membership. Applicants should complete the application form and return this to the chairperson. The application form will be circulated to the EPAG membership. At least a majority vote of members is required for acceptance.
1.18.2	Applicants may re-apply at any time by following the same procedure.
1.18.3	Member companies at any time may withdraw from EPAG. Re-application is allowed as above. Any outstanding costs should be honoured by the company withdrawing.
1.18.4	A member company may be excluded from EPAG if they do not fulfil the criteria for membership, bring EPAG into disrepute or are not in line with the EPAG objectives, greater than 75% of the member companies vote in favour of exclusion.
1.18.5	Mergers of one (or more) EPAG member companies into a joint company shall result automatically in the membership of the joint company. The joint company shall have one vote and shall be represented by one individual. The same shall apply if one (or more) non-EPAG companies merge with one (or more) EPAG member companies.
1.18.6	Companies joining EPAG within the first 6 months of the year will pay the subscription fee in operation at that time. Companies joining in the second half of the year will not be asked to pay the subscription fee.
1.19	Any member may propose a change to the constitution or to the objectives, adoption requires at least a 75 % majority vote of member companies.
1.20	EPAG subgroup activities are bound by the EPAG constitution.
1.21	EPAG members need to be aware of competition guidelines and anti-trust legislation that govern discussions and are cautioned against any reference to commercially sensitive information. This includes, but is not restricted to, information in regard to current or projected prices, price changes, price differentials, discounts, allowances, terms or conditions of sale; industry pricing policies, price levels or price changes; changes in production capacities or inventories; individual company bids or intentions to bid; matters relating to suppliers (actual or potential) that might effect excluding them from any market or business conducted towards them; company market share for any product.
2.	EPAG Objectives
	Sharing of non-confidential information: To focus on Pharmaceutical issues relevant to Pulmonary and Nasal Delivery products, including clinical aspects as appropriate. Establish scientifically based best practices. Provide consensus comment to Industry and Government Agencies to promote safety and quality standards. To recommend harmonised standards and methodology
3.	Membership Criteria
	Membership of EPAG is open to “European Pharmaceutical Companies that develop new drug product for human use utilising the Pulmonary or Nasal route of delivery”. A Pharmaceutical Company is a company responsible for the development of the drug product. It would normally have its own Research and/or Development capability, and the capability to submit, applications for product licenses. It is recognised that product development will take place in collaboration with other Pharmaceutical companies as well as non-Pharmaceutical companies (e.g. Active Pharmaceutical Ingredient (API) suppliers, device design and componentry manufacturers, consultants etc). These companies may be invited to attend when a particular need is identified. Companies, including non-European companies, may be admitted as members where they provide specific expertise that supports and enhances EPAG objectives.  Publication Policy:
	Scope:  To assess all EPAG external publications, whether from the plenary EPAG members or sub-teams of EPAG (including but not limited to publications (written or oral) made at conferences or as posters and in peer reviewed journals). But excludes those responses to external agencies that are agreed by a separate review process.   Considerations Publications must be scientifically robust and provide a worthwhile contribution. Quality of work, completeness and content shall take precedence over speed to publish. Proposals for publication must be submitted in a timely manner Full text, diagrams etc and details of where and when the publication is being made, plus the deadline for submission. Publication without prior consent will result in those responsible having to provide a full justification to EPAG for that action. All publications must clearly state that it is an EPAG publication. Wherever possible publications are for public use and are freely available to copy for private use. Process Proposal from an sub team or plenary EPAG member shall be made to EPAG plenary members EPAG plenary members shall review the proposals and nominate a review panel. Lead author &/or sub team leader shall circulate the final draft publication to all plenary EPAG members. Any plenary EPAG member can object within a two week period and shall provide a substantive rationale. If appropriate any objections shall be discussed by plenary EPAG members. A unanimous acceptance to publish must be made by the review panel. Approval to publish must be included in the meeting minutes of the relevant sub-team or plenary meeting.