S.L. 483.9 Art. 3Levy of fees. Fee for the annual renewal of a licence €3,000 €5,000 €7,000 €10,000 in € €1,000 per Inspector spent for and for per day (including for actual for travel) per day (including for actual for travel) if Application connection storage or intended for Consultation

(1) There shall be paid to the Licensing Authority the fees specified in the Schedule in respect of the issuance of, renewal of and, or the substantial change to a license as provided for in the Act.

(2) No fee under the provisions of these regulations shall exempt the charge of any other fees payable to other competent authorities with regards to any licence, permit or authority imposed by any other regulation or other law.

(3) Any additional expenses incurred by the Licensing Authority shall be charged separately, which additional expenses may include inspections in third countries tissues establishments.

(4) For applications involving an inspection in a third country outside the European Union the applicant has to additionally cover for the cost of the flight, all the accommodation expenses of the inspectors, all visa costs which may be incurred, any immunisations which may be necessary, transport costs and any other expenses which may be reasonably incurred.

(5) In exceptional circumstances and, or at the discretion of the Licensing Authority, waivers for and, or reduction in fees due under these regulations may be granted.

(6) Fees for academic research without support from industry shall benefit from a fee waiver of 70% of the full fee. The exemption shall be at the discretion of the Licensing Authority.

(7) The waivers and, or reduction referred to in this regulation shall be provided for in writing to the applicant. SCHEDULE (Regulation 3) License and Inspection Fees

Type of Application Fee for the

(involving an inspection in issue of a

Malta or within the Type of Facility licence and/

European Union/European or initial

Economic Area) inspection Micro (0-9 employees) (Includes all the personnel employed within the facility) €5,000 Small (10 to 4 9 Application for the issuance of a licence to carry out any employees) (Includes all the personnel employed activity in connection with within the facility) €7,000 testing, processing, preservation, storage or Mediu m (50 to 24 9 distribution of human tissue employees) (Includes all and cells intended for human the personnel employed applications within the facility) €10,000 Large (more than 250 employees) (Includes all the personnel employed within the facility) €15,000 Variation - Application for approval to make an administrative/ non technical office based change in activities €300 Variation - Application for approval to make a substantial change in activities €2,500

Type of Application Fee (Involving an inspection in a third country outside the European Union/ European Economic Area) Application for an inspection related to any activity in €15,000 plus connection with testing, processing, preservation, d ay per storage or distribution of human tissue and cells (including days intended for human applications actual inspection travel) Requirement for additional inspection €5,000 plus €1,000 per Inspector days spent inspection and Annual fee (if applicable in case of issuance of license €5,000 plus €1,000 and/or certificate and/ or equivalent per Inspector days spent inspection and applicable for an inspection related to any activity in €15,000 plus €1,000 per with testing, processing, preservation, day per Inspector distribution of human tissue and cells (including days spent for human applications actual inspection and for travel) (per man hour) €50