http:// www.crownacademy.ca All unauthorized reproduction is prohibited. 1 PHARMACEUTICAL REGULATORY AFFAIRS IN SPAIN May, 2015 Professor: Peivand Pirouzi, Ph.D., MBA Post-Graduate Certificate in Regulatory Affairs and Drug Submission Crown Medical Research and Pharmaceutical Sciences College of Canada
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http://www.crownacademy.ca
All unauthorized reproduction is prohibited.1
PHARMACEUTICAL REGULATORY
AFFAIRS IN SPAIN
May, 2015
Professor: Peivand Pirouzi, Ph.D., MBA
Post-Graduate Certificate in Regulatory Affairs and Drug Submission
Crown Medical Research and Pharmaceutical Sciences
A. Ministry of Health: Rule on all healthcare issues.
B. AEMPS - Agency on Medicinal Products and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios)– Grant, modification, revocation of manufacturing and
marketing authorisations.
– Authorisation of clinical trials.
– Promotion, control and supervision of medicinal products in the market.
• Reimbursement is by a system of reference pricing.– Reference prices are the maximum amount the
NHS will fund for each medicinal product in a group.
– Group : the total of financed medicinal product's presentations that have the same active ingredient and identical administration route (at least one must be a generic or biosimilarmedicinal product or its main AI been authorised within Spain or the EU for ten years – RD 177/2014).
– Reimbursement is normally paid by the NHS to the pharmacist. 14
• NO Restrictions on foreign applicants Key stages and timing
– AEMPS makes a reasoned decision within 90 days of the application.
– If all requirements are met, AEMPS grants the authorisation. Entered in the ‘Registry of Pharmaceutical Laboratories’.
– If applicant fall, it is communicated and have 15 days to provide the relevant information. If the AEMPS does not communicate a decision within three months of the application's submission, the application is dismissed.
– Right of appeal to AEMPS and then to a court. 16
• Regulated by Royal Decree 223/2004 on clinical trials.
• Authority– AEMPS is the authority responsible for approval of clinical trials.
– Requires a favourable opinion from the Ethics Committee on Clinical Investigation (1)
– Requires the approval of the centres where CT are carried out.
• Consent
– A participant in a clinical trial must consent to participation after having understood, the objectives, risk, inconveniences, conditions and right to withdraw.
– Consent documented in specific form.
• Trial Pre-conditions: – Sponsors are responsible for obtaining insurance to cover any harm that could
arise to trial subjects as a consequence of the trial
• Procedural requirements– The trial must be performed according to the trial protocol, legal and ethical
regulations, and good clinical practices.
20(1) Independent organisation accredited by health authorities of the Autonomous communities and the AEMPS.
• Timing– Trials requiring AEMPS' prior written authorisation and subject to
special procedure. • Trials where the AEMPS has notified objections to the sponsor.
• Trials that refer to products requiring a qualification as products under clinical investigation. Pharmaceutical forms of active ingredients which are:
– Used or combined differently form the authorised form;
– Used to treat an unauthorised symptom; or
– Gain more information on the authorised use.
– If no response to application within 60 days, the application is deemed refused
• Trials that are undertaken with medicinal products relating to:– gene therapy;
• Plants, plant mixtures and preparations obtained from plants with therapeutic or preventive use are subject to laws governing magisterial formulae, officinal preparations or pharmaceutical specialties.
• Plants traditionally considered as medicinal plants that are offered without reference to therapeutic, diagnostic or preventive properties, can be freely sold to the public but only at authorised establishments.
• A list of the permissible traditional plants is established by the Committee on Herbal Medicinal Products (HMPC) of the EMEA.
• Ministry of Health has published a list of plants whose sale to the public is restricted or prohibited due to their toxicity (Order SCO/190/2004).
Key stages and timing (Royal Decree 1345/2007)– 210 days for AEMPS to decide whether to grant or refuse the
application.• If the application is not complete, AEMPS gives the applicant ten days to
provide the required documentation. This interrupts the 210-day period.
• If this information is not provided, AEMPS informs the applicant and, after three months, the application expires.
• The Committee for the Evaluation of Medicinal Products for Human Use, an official body of AEMPS, issues a non-binding report during the 210-day period.
• AEMPS makes a final decision on the application within ten days of the Committee's report.
– AEMPS' decision sets out the medicinal product's marketing conditions, including the text, labelling and packaging requirements to comply with the Summary of Product Characteristics (Technical Deed).
– At the same time, the product is also entered into the Registry of Medicinal Products (Registry). 26
Marketing• Abridged procedure = not required to provide the
results of pharmacological or toxicological tests or clinical trials– The application is made with the consent of a MA holder of
a medicinal product with the same qualitative and quantitative composition and identical pharmaceutical form.
– The active ingredient (AI) of the medicinal product has a clearly established medicinal use of at least ten years in the EU, with known efficacy and an acceptable level of security established by a detailed scientific bibliography.
– The medicinal product is a generic of a reference medicinal product authorised under EU regulations for a minimum period of eight years. The generic however cannot be marketed in Spain until ten years have elapsed since the initial MA was granted (or 11 years if a relevant new indication is subsequently authorised).
• Mandatory mutual recognition of MA granted by EU member states.
If an application for MA of a medicinal product has already been examined by another member state's health authority:
– AEMPS suspends examination of the application until it receives a report from that health authority.
– Within the following 30 days, AEMPS must either:• Grant the authorisation.
• Start a consultation period in which representations of the applicant and the relevant member states are obtained.
• If AEMPS still refuses to accept the application, a Commission conciliation procedure starts, following which the Commission issues a final decision.
• Process and timing – Obtain registration lasts between 30 and 36
months. A rejection can be appealed before the administrative courts.
– Patent rights last 20 years from the date the application (if renewal fees are paid and the patent is not revoked)
– Patents cannot be extended beyond a term of 20 years, except for medicinal products.
– Patent rights for medicinal products can be extended by a supplementary protection certificate (SPC), for a period of up to five years (1).
(1) Equal to the period between the date when the patent application was lodged, and the date when the first marketing authorisation was granted in the EU, minus a period of five years. Regulation (EEC) No. 1768/92.
Trade marks• Spain is party to the following international conventions:
– Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health. CETS No.: 211 (Medicrime convention).
• Ratified by 4 countries. Ratified by Spain on August 5, 2013.
• Signed by19 countries.
• International tool which criminalizes counterfeiting and the production and distribution of medical products put on the market without approval or in violation of safety standards.
– WIPO Paris Convention for the Protection of Industrial Property 1883.
– Patent Cooperation Treaty 1970.
– Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure 1977.
– WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS).
• Regulations– Civil Code, which applies to contractual or extra-
contractual (that is, tortious) liability.
– Royal Decree 1/2007, 16 November 2007, which harmonises product liability rules for defective products.
• Liability– The manufacturer and importer are liable for damage
caused by a defect in a product which they have manufactured or imported.
– Other persons involved in the manufacture, import or sale of the defective products (or other operation relating to the marketing of the defective product) can be liable for damage attributable to them.
• Regulations– Civil Code, which applies to contractual or extra-contractual (that
is, tortious) liability.• Limitation periods are 15 years contractual liability and one year for
extra-contractual.
– Royal Decree 1/2007, 16 November 2007, which harmonises product liability rules for defective products.
• Limitation period of three (3) years from the day on which the claimant suffers the damage. Ten (10) years from the date on which the product which caused the damage was put into circulation.
• Liability– The manufacturer and importer are liable for damage caused by
a defect in a product which they have manufactured or imported.
– Other persons involved in the manufacture, import or sale of the defective products (or other operation relating to the marketing of the defective product) can be liable for damage attributable to them.
• Hector Jausas and Maria Cedó . Medicinal product regulation and product liability in Spain: overview. Life Sciences. Multijurisdictional guide 2014-2015. ( Law stated as 1 May 2014)
• Europe in 12 lessons (2014) . 2014, European Commission, Directorate-General for Communication.
• European Union. Official website. http://europa.eu/index_en.htm
• European Medicines Agency. Official website. http://www.ema.europa.eu
• Agencia Española de Medicamentos y Productos Sanitarios. (Spanish Agency of Medicines and Health Products). http://www.aemps.gob.es/