ASL TERAMO
ACCREDITATION: the relevant request must be sent to the «Drug Scientific Representative Accreditation» Office by completing and sending Model 1 «Company accreditation request» which must be sent by email to the address accreditamento.isf@aslteramo.it . Companies must provide their ISF with an identification card, accompanied by a photo, in the absence of which the informant's access to company structures is prohibited.
ACCESS: for access purposes, all ISFs must be registered in the appropriate list of the Local Health Authority of Teramo and show their identification card, together with their identity document, where required.
VISITS: the scientific information activity cannot be carried out within the UU.OO. during the hours intended for the visit / assistance of patients. Suitable venues and special time slots. Individual visits, preferably by appointment or collegial. Visits maximum 5/year.
DATA TRANSMISSION: half-yearly (31.01-31.07) GP/PLS: visits at specific times
ACCESS LOG: the traceability of visits takes place in a special computerized register, inserted in a shared folder, by the Prescribing Medical Director. Furthermore, further checks are carried out by the Scientific Information Coordinator and by the Accreditation Office.
PHARMACY ACTIVITY: it is forbidden to provide data by health professionals and to request data from the ISF.
FREE SAMPLES: the request for free samples by the prescribing Medical Executives must take place by completing Model 8 which must be delivered to the ISF and to the hospital pharmacies who enter the data in a specially prepared file. They then have to fill in Form 9 «Free Sample Delivery», obtain authorization from the unit to which they belong and send the completed form to the hospital pharmacies.
GIFTS: pharmaceutical companies must notify the Accreditation Office of gifts with a negligible value or in any case not exceeding €20, distributed to doctors and pharmacists and the relative value (including magazines and subscriptions). Information material with a value greater than negligible: only to Local Health Departments. Communication to the ASL of the gifts being distributed and their relative value.
SURVEILLANCE: the supervision of the activities and work of the ISFs is delegated to the control by the Directors/Managers of the structures concerned. PHARMACOVIGILANCE: the ISF must transmit to the ASL every adverse reaction of which they become aware.
REGION
ACCREDITATION: card issued by pharmaceutical companies, authenticated by the Region.
SSR STRUCTURES: suitable premises and reception calendars preferably by appointment with individual or group visits organized with the departments concerned.
GP/PLS: visits at specific times
VISITS: generally 5/year/doctor
AREA HEAD (or other professional figures not related to the IMS): coaching only for inexperienced FSIs or for specific reasons to be presented to the doctor (organization of training events, research projects)
DATA TRANSMISSION: annual (January 31st) with average number of visits. Transmission of each change in the list of names communicated within 30 days to the pec address: ufficio.prestazioni.assistenziali.farmaceutico@cert.regione.basilicata.it
MONITORING TABLE: (Provincial Orders of Doctors, Provincial Order of Pharmacists, General Practitioners, Pediatricians, Farmindustria, Association of ISFs, ASL, Doctors employed by the NHS) have the task of verifying, identifying irregularities and applying sanctions
PHARMACY ACTIVITIES: commercial activity prohibited. It is forbidden to ask about prescriptive habits PHARMACOVIGILANCE: fulfilments in accordance with Legislative Decree of 30 April 2015
FREE SAMPLES: Equivalent drugs on the AIFA transparency list: free quantityor (DGR 1051/2010) < 18 MONTHS: 2/visit max 8/year;
> 18 months: 4/visit max 10/year
❖ Level C: unlimited
GIFTS: negligible value 20 euros/doctor/year. Texts, scientific journals of higher value only in favor of the Operational Units. For general practitioners and paediatricians of free choice, the transfer is made to the district of competence, unless otherwise agreed between contracted doctors and the health company
INFORMATION MATERIAL: only the one approved by AIFA was used
CONFERENCES AND CONGRESSES: fulfilments in accordance with art. 124 Legislative Decree April 24, 2006
REGION
ACCREDITATION: card issued by the Region
SSR STRUCTURES: suitable premises, individual visits preferably by appointment or collegiate visits in time slots agreed by the Managements themselves or department manager/operating unit
GP/PLS: visits at specific times
VISITS: max. 4/year/doctor (max. 4/year for the same active ingredient).
AREA HEAD (or other professional figures not related to the IMS): coaching in the first 12 months of activity and/or for functions other than scientific information
DATA TRANSMISSION: six-monthly (January 31st-July 31st) with average monthly visits. Transmission of any change to the list of names communicated within 30 days.
MONITORING TABLE: (Region, ASL, FULC, employed and affiliated doctors) with tasks of verification, identification of irregularities and application of sanctions
PHARMACY ACTIVITIES: commercial activity prohibited. It is forbidden to ask for data on prescriptive habits PHARMACOVIGILANCE: the ISFs must transmit to the ASL every adverse reaction they become aware of
FREE SAMPLES:
< 18 MONTHS: 2/visit max 8/year;
➢ 18 MONTHS: 5/visit max 20/year; ❖ Band C: unlimited
GIFTS: negligible value 20 euros/doctor/year. Texts, scientific journals of higher value only in favor of the Operational Units. For general practitioners and paediatricians of free choice, the transfer is carried out at the district of competence, unless otherwise agreed between contracted doctors and the health company. Communication to the ASL of the gifts being distributed and their relative value
INFORMATION MATERIAL: only the one approved by AIFA was used
CONFERENCES AND CONGRESSES: both the company and the doctor communicate their participation to the ASL they belong to.
SANCTIONS: exclusion from tenders, scientific information and release of free samples, fines also correlated to the sales volume.
AO PUGLIESE-CIACCIO (CZ) – REG. MAY 25, 2018
ACCREDITATION: request to the General Management. Card issued by Pharmaceutical Companies
VISITS: max. 6/year/doctor in dedicated premises and hours, individual by appointment and collegial.
PHARMACY ACTIVITIES: healthcare professionals cannot provide information on prescribing habits, nor can ISFs ask for it.
GIFTS: negligible value 20 euros/doctor/year. Information material with value greater than negligible: to Operating Units only. Communication to the DG of the gifts being distributed
CONFERENCES AND CONGRESSES: both the company and the doctor communicate their participation in the structure they belong to.
REGION
ACCREDITATION: card issued by pharmaceutical companies, authenticated by the Region
SSR STRUCTURES: suitable premises and reception calendars preferably by appointment with individual or collective visits organized with the departments concerned or by the department manager or by the operating unit
VISITS: visits at a specific time/ 6/year/doctor (except at the discretion of the doctor)
AREA HEAD (or other professional figures not related to the IMS): coaching in the first 12 months of activity or for functions other than scientific information.
DATA TRANSMISSION: six-monthly (January 31st-July 31st) with average monthly visits. Transmission of any change to the list of names communicated within 30 days to the address: dg04.farmaceutica@pec.regione.campania.it
MONITORING TABLE: (also with the participation of a representative of the ISF category) with tasks of verification, identification of irregularities and application of sanctions
PHARMACY ACTIVITIES: commercial activity prohibited. Information on doctors' prescribing habits can neither be requested by the ISF nor provided by health professionals
PHARMACOVIGILANCE: the ISFs must transmit to the ASL every adverse reaction they become aware of
FREE SAMPLES:
< 18 months: 2/visit max 8/year; > 18 months: 4/visit max 10/year
GIFTS: negligible value 20 euros/doctor/year. For general practitioners and paediatricians of free choice, the transfer is made to the district of competence, unless otherwise agreed between contracted doctors and the health company
INFORMATION MATERIAL: only the one approved by AIFA was used
CONFERENCES AND CONGRESSES: both the company and the doctor communicate their participation to the AO and the ASL they belong to. OPERATING REGULATION: will be issued by the Department of Health
AO S. JOHN OF GOD AND RUGGI D'ARAGONA (SA)
VISITS: 3/year/doctor; individual by appointment or preferably collegial, in specific premises
SSR STRUCTURES: suitable premises with individual visits or preferably collegiate visits outside the hours intended for assistance activities ACCESS LOG: established in order to register the accesses of the ISF
INFORMATION MATERIAL: copy used for the IMS activity to be filed with the Medical Directorate
AO MONALDI-COTUGNO-CTO (NA)
ACCREDITATION: prior request to the General Management of the AO
VISITS: collegial visits (also in the presence of a pharmacist) and individual visits only in case of impossibility by the ISF. Visits maximum 6/year/doctor ACCESS LOG: established in order to record the accesses of the ISF
CONFERENCES AND CONGRESSES: companies must communicate the names to the General Management
FREE GIFTS: texts, subscriptions to scientific journals only in favor of the Operative Units
PHARMACY ACTIVITY: Prohibited from providing information on prescriptive habits PO G. RUMMO
RESOLUTION 513/2017
VISITS: in dedicated places and times. Maximum 6/year/doctor
PHARMACY ACTIVITY: it is forbidden to ask for information on prescribing habits and to provide them by health professionals CONFERENCES AND CONGRESSES: healthcare professionals must communicate their participation to the DG
GIFTS: of negligible value (€20/company/doctor)
IRCCS «GIOVANNI PASCALE FOUNDATION» (NA)
DG RESOLUTION N.845 OF 10.25.2018
ACCREDITATION: prior request to the Management of the AO, for a maximum number of 10 Representatives for each company. For the purposes of authorisation, for the ISF a copy of the identification card endorsed by the Campania Region is required. All the information is reported in Form 01POG26_Register of authorized informants, published on the Institute's website and transmitted, once the authorization has been issued, to the Medical Department of the Unit which will provide for their dissemination to the Clinical Assistance Structures and to the Pharmacy SC.
VISITS: Individual, by appointment with the professional or collective/multidisciplinary organized by the Department Directors. Furthermore, visits cannot take place in the care areas, in specialist outpatient clinics during visiting hours or in such a way as to interfere with the regular performance of the care activity. Visits maximum 6/year/doctor
ACCESS LOG: Registration takes place before each access, at the Medical Directorate of the Unit, using a special form (Mod.02POG26_Registroaccessi). There is no registration for investigational drugs. After registration, an entry pass is issued, to be shown for access to the facilities. As for accesses, a maximum number of 6 accesses per year is established, for each healthcare professional, unless there is a need to communicate new information on the appropriate use of medicines. Furthermore, this limit does not apply to experimental drugs.
GIFTS: any gifts are allowed only when their negligible value does not exceed twenty euros per year, for each Company and for each operator. As for free samples, a distinction is made between two hypotheses: 2 samples (per visit and per dosage) exclusively in the 18 months following the first marketing of the product and for a maximum of 8 samples per year: when the medicinal product has been on the market for more than 18 months , the limit is a maximum of 4 samples per visit and a maximum of 10 samples per year.
PHARMACY ACTIVITY: Prohibited from providing information on prescriptive habits
REGION
ISF Emilia Romagna Regulation Application 20.01.20
ACCREDITATION: necessary accreditation for all (not only ISF) on the regional portal (also for the access register) FREE SAMPLES: art. 125 Legislative Decree 219/2006; Cnn only if authorized by the company management
CONFERENCES AND CONGRESSES: le Pharmaceutical and healthcare companies communicate their participation in the structure to which they belong VISITS: 5/year/doctor
GP/PLS: outside the visiting hours
SSR STRUCTURES: suitable premises and dedicated time slots
GENERAL DIRECTORATE DEPARTMENT: meeting request with topic of discussion
GIFTS: negligible value 20 €/doctor/year. Informative material with value higher than negligible only to ASL/AO health directorates PHARMACY ACTIVITIES: it is forbidden to provide information by health professionals
GIFTS: negligible value €20, material of greater value only to company management
FREE SAMPLES: Legislative Decree 219/2006 art.125. Cnn to be authorized by the Health Directorate
Coaching: Both in the context of visits to the SSR structures and in the MAP/PLS outpatient clinics, the ISFs must carry out their activity with the doctors alone; the presence of the area manager or other professional figures not related to the scientific information activity is allowed only for functions other than scientific information.
ACCESS LOG: computerized, filled in by all business representatives.
AUSL BOLOGNA-RESOLUTION 222/2017
SSR STRUCTURES: suitable premises and dedicated time slots. Collegial or exceptionally individual meetings by appointment
GP/PLS: dedicated time slots or by appointment
VISITS: 5/year/doctor
GIFTS: negligible value 20 euros/doctor/year. Informative material with value higher than negligible only to ASL/AO health directorates
FREE SAMPLES: art. 125 Legislative Decree 219/2006; Cnn only if authorized by the company management
CONFERENCES AND CONGRESSES: Pharmaceutical and healthcare companies communicate their participation in the structure they belong to PHARMACY ACTIVITIES: health professionals cannot provide information
AUSL FERRARA-RESOLUTION 218/2017
SSR STRUCTURES: table with dedicated times and venues for each ASL structure. Meetings preferably by appointment, collegial e
multidisciplinary
GP/PLS: dedicated time slots or by appointment
PHARMACY ACTIVITIES: health professionals cannot provide information VISITS: 5/year/doctor
AUSL IMOLA-RESOLUTION 7/2016
ACCESS LOG: set up. Quarterly reporting of visits
Each visit must be requested from the Pharmacy Service through a special form module. The request must be authorized within 10 working days. Hours (12-18) and dedicated venues. The ISF and the OU director must sign the report of the visit using the appropriate form.
AUSL PARMA RESOLUTION 480/2017
VISITS: certificate at the end of each visit
SSR STRUCTURES: dedicated premises and times also for meetings with pharmacists
GP/PLS: outside the visiting hours
CONFERENCES AND CONGRESSES: pharmaceutical and healthcare companies communicate their participation to the structure they belong to
AUSL REGGIO EMILIA - Procedure 56/2019
SSR STRUCTURES: dedicated locations and times. Individual visits by appointment or preferably collegial GP/PLS: by appointment or at special times
VISITS: maximum 5/year/doctor
ACCESS LOG: computer scientist
GIFTS: negligible value €20, material of greater value only to company management PHARMACY ACTIVITIES: it is forbidden to provide information by health professionals
AUSL ROMAGNA - Procedure 134/2018
SSR STRUCTURES: dedicated locations and times VISITS: maximum 5/year/doctor
GIFTS: negligible value 20 €/doctor/year. Informative material with value higher than negligible only to ASL/AO health directorates. ACCESS LOG: set up
CONFERENCES AND CONGRESSES: health professionals communicate their participation to the structure they belong to
PHARMACY ACTIVITIES: health professionals cannot provide information
FREE SAMPLES: art. 125 Legislative Decree 219/2006; Cnn only if authorized by the company management
AO S. Orsola (BO) Resolution 110/2017
ACCESS LOG: electronic
VISITS: individual by appointment or collegial. Maximum 5/year/doctor in dedicated premises and hours. PHARMACY ACTIVITY: health professionals cannot provide information.
FREE SAMPLES: article 125
CONFERENCES AND CONGRESSES: Pharmaceutical companies communicate the participation of healthcare professionals.
Appointment via the form available on the company website. The AOU, after evaluating the request, indicates the date and place of the appointment.
SSR STRUCTURES: dedicated locations and times VISITS: maximum 5/year/doctor
GIFTS: negligible value 20 €/doctor/year. Informative material with value higher than negligible only to ASL/AO health directorates. ACCESS LOG: at each operating unit
CONFERENCES AND CONGRESSES: pharmaceutical and healthcare companies communicate their participation to the structure they belong to. Training is permitted if it brings benefit. Non-nominative proposals
PHARMACY ACTIVITIES: health professionals cannot provide information
FREE SAMPLES: art. 125 Legislative Decree 219/2006; Cnn only if authorized by the company management
RIZZOLI ORTHOPEDIC INSTITUTE RESOLUTION 250/2015
VISITS: in dedicated places and times
ASUGI-Giuliano Isontina University Health Authority REG_01_00_DG of 11.08.20
ACCREDITATION: Companies must send an accreditation request to the SC Medical Department of the Ospedale Maggiore, filling in the appropriate form (made available on the website, together with these regulations). The form, which contains the information required by current legislation and any further deemed essential by ASUGI, must be presented by the Company concerned with the information relating to each professional for whom access authorization is requested. The request must be forwarded by sending it to the PEC address of the Company.
Accredited companies must provide their IS with an identification card including a photo.
SSR STRUCTURES: each facility manager identifies a suitable place for carrying out the IS activity; days and time slots are defined for IS access. The days and times for the meetings are made public by publication on the corporate website and at the entrances of the individual structures. In the case of collective meetings, suitable premises can be identified and made available by the Management of the DAT/DAO, where not available within the structures involved.
VISITS: : 5/year/doctor; individual by appointment with the individual professional or collegial organized by the Heads of Department / Structure or their delegates. The same limit (five individual visits per doctor) applies if a IS is responsible for the IS service of several products: exceptions to the maximum number of visits per year are allowed due to the need to convey new and relevant information on the use of medicines (e.g. new therapeutic indications, warnings about adverse events, side effects, etc.). In the event that the scientific information concerns the presentation of a medical device or a health technology, the SC Engineering Clinic or other corporate technical structure is involved for the assessments of competence.
Coaching: In compliance with the provisions of the guidelines of the Conference of Regions and Autonomous Provinces, accompaniment is not permitted
ACCESS LOG: set up
FREE SAMPLES: Article 125 of Legislative Decree 219/2006,
CONFERENCES/CONGRESSES: As regards the participation of personnel in external training events sponsored by companies/companies, the provisions of the specific company regulation apply.
SURVEILLANCE: The supervision and control of the provisions contained in these regulations is guaranteed by the SC Medical Department of the Cattinara- Maggiore Hospital with reference to the phases relating to the accreditation of the Companies and the authorization to access the IS, the keeping of the register of authorized ISs, to the revocation of the authorizations already granted where the foreseen conditions occur. Each Director of the structure is responsible for keeping the Visits Register and for supervising and controlling compliance with the internal provisions regarding the methods of carrying out the visits, providing for reporting to the Health Department any different behaviors found by the ISs or by the professionals involved in the information activity scientific. The Nursing Coordinator of the Operating Complex is responsible for keeping the entry register of product specialists.
ARCS
ACCREDITATION: accreditation request form; card issued by pharmaceutical companies for all their representatives at ARCS
VISITS: : individual by appointment or collegial.
FREE GIFTS: negligible value €50/doctor/year
ACCESS LOG: set up for ISF only
PHARMACY ACTIVITY: business representatives cannot ask for information
CENTRAL FRIULI UNIVERSITY HEALTH CENTER DECREE 1384/2020
ACCREDITATION: form (http://asufc.sanita.fvg.it ) to be sent to asufc@cerstsanita.fvg.it ; maximum 5 ISF; card issued by Pharmaceutical Companies.
VISITS: individual by appointment or collegial; maximum 5/year/doctor; suitable premises and dedicated time slots other than the viewing ones PHARMACY ACTIVITIES: health professionals cannot provide information
ACCESS LOG: set up
INTEGRATED UNIVERSITY HEALTH CENTER OF UDINE: REG. 1020/2019
ACCREDITATION: Companies must send a request for authorization to the Health Department by completing the form «Authorization request from the manufacturing companies for information-scientific activity» and sent via pec asuiud@certsanita.fvg.it. A maximum number of 5 ISFs must be indicated on the form. The card is provided by the pharmaceutical company, subject to approval and authorization of the documentation sent by the company.
SSR STRUCTURES: suitable premises and agreed time slots and in any case different from those of the visit VISITS: 5/year/doctor; individual by appointment or collegial
ACCESS LOG: set up
CONFERENCES AND CONGRESSES: the participation of Company employees in external training events sponsored by External Companies/Companies, please refer to the consultation of the ASUIUD FOR_REG_01 regulation "Regulation on the participation of individual employees in training events external to the Company with expenses borne by private subjects (individual sponsorships)”, version n.01 of 15/01/2018.
FREE SAMPLES: art. 125 Legislative Decree 219/06
INTEGRATED UNIVERSITY HEALTH CENTER TRIESTE: REG 908/2019
ACCREDITATION: Companies must send a request for authorization to the Health Directorate for a total number not exceeding 5 ISF (including the number of Specialists) and forwarded by PEC. THE card issued by the Pharmaceutical Companies.
VISITS: individual by appointment or collegial; maximum 5/year/doctor, suitable premises and dedicated time slots other than visiting hours
ACCESS LOG: set up
FREE SAMPLES: art. 125 Legislative Decree 219/06
HEALTHCARE COMPANY LOWER FRIULANA ISONTINA
ACCREDITATION: Companies must send an authorization request to the company Single Pharmacy using the appropriate Attachment 1. A maximum number of 10 ISFs (including the number of Specialists) must be indicated on the form. The card is provided by the pharmaceutical company, subject to approval and authorization of the documentation sent by the company.
SSR STRUCTURES: suitable premises and agreed time slots and in any case different from those of the visit. For medical-surgical devices, the Specialist can attend medical-surgical procedures for technical-application and training support and access the operating theaters with the authorization of the Head of the facility.
VISITS: 5/year/doctor; individual by appointment or collegial FREE SAMPLES: art. 125 Legislative Decree 219/06
CRO AVIANO-ONCOLOGICAL REFERENCE CENTER
ACCREDITATION: card issued by Pharmaceutical Companies;
VISITS: 5/year/doctor; individual by individual appointment (an exception to collegiate meetings) or collegiate, suitable premises and dedicated time slots different from those for visits ACCESS LOG: set up
FREE GIFTS: negligible value € 20/doctor/year
REGION
ACCREDITATION: card issued by Pharmaceutical Companies;
SSR STRUCTURES: suitable premises and preferably by appointment with individual or collegial visits organized with the departments concerned
GPs/PLS: visits at specific times, preferably different from the visit time
VISITS: 5/year/doctor
AREA HEAD (or other professional figures not related to the IMS): support allowed only for functions other than scientific information
DATA TRANSMISSION: annual (January 31st). Transmission of any change to the list of names communicated within 30 days. At the following address: politicadelfarmaco@regione.lazio.legalmail.it
MONITORING TABLE: the company departments (ASL and AO) have the task of verifying, identifying irregularities and applying sanctions ACTIVITY IN THE PHARMACY: commercial activity is prohibited. It is forbidden to ask for information on prescriptive habits
FREE SAMPLES:
< 18 MONTHS: 2/visit max 8/year; > 18 months: 4/visit max 10/year
GIFTS: negligible value 20 euros/doctor/year. Texts, scientific journals of higher value only in favor of ASL/AO. For general practitioners and paediatricians of free choice, the transfer is carried out at the district of competence, unless otherwise agreed between contracted doctors and the health company.
Communication to the ASL of the gifts being distributed and their relative value
INFORMATION MATERIAL: only those approved by AIFA were used.
CONFERENCES AND CONGRESSES: both the company and the doctor communicate their participation to the AO and the ASL they belong to
A. GEMELLI POLICLINIC
ACCREDITATION: request to the pharmacy UOC to accredit the company and the individual ISFs
PHARMACY ACTIVITIES: health professionals cannot provide information nor can the ISFs ask for it VISITS: individual by appointment or preferably collegial
TO SAN CAMILLO-FORLANINI
VISITS: Tuesday and Friday 14-17
ACCESS LOG: established in order to register the accesses of the ISF and held by the UOC pharmacy which will issue a certificate of registration that the subject must show to the interlocutor at the time of access
REGION
ACCREDITATION: card issued by Pharmaceutical Companies
SSR STRUCTURES: suitable premises and dedicated time slots
FREE SAMPLES: art. 125
CONFERENCES AND CONGRESSES: the health professionals communicate their participation in the structure they belong to VISITS: at a specific time preferably different from that of the visit
DATA TRANSMISSION: annual (January 31) : welfare@pec.regione.lombardia.it INFORMATION MATERIAL: articles 121 and 122 Legislative Decree 219/06
PHARMACY ACTIVITIES: articles 120 and 121 Legislative Decree 219/06
PIO TRIVULZIO HOTEL
ACCREDITATION: card issued by Pharmaceutical Companies SSR STRUCTURES: suitable premises and dedicated time slots
FREE SAMPLES: art. 125
VISITS: facilitate collegiate meetings
ACCESS LOG: set up (fill in the "ISF access authorization" form on first access) SURVEILLANCE: spot checks using the appropriate form
ASST MONZA REGULATION OF 16.09.20
ACCREDITATION: annual authorisation, card provided by the Pharmaceutical Companies FREE SAMPLES: art. 125
CONFERENCES AND CONGRESSES: art 124 Legislative Decree 219/2006
VISITS: 3 visits/year, suitable premises and dedicated time slots
MEETING: with prior authorization
PRIZES AND FINANCIAL BENEFITS: art 123 Legislative Decree 219/2006 ACCESS LOG: set up
REGION
ACCREDITATION: card provided by pharmaceutical companies
SSR STRUCTURES: suitable premises, individual visits preferably by appointment or collegiate visits in time slots agreed by the Managements themselves or department manager/operating unit
GP/PLS: visits at specific times according to methods agreed with the doctor
VISITS: 4 visits/year/doctor
AREA MANAGER (or other professional figures): coaching for new hires or for the first 12 months of activity and/or for functions other than scientific information
PHARMACY ACTIVITIES: commercial activity prohibited. It is forbidden to ask for information on prescriptive habits
DATA TRANSMISSION: transmission of any change to the list of names communicated within 30 days to the address: region.marche.assistancefarmaceutica@emarche.it
MONITORING TABLE: (Representative of the Provincial Order of Doctors, Provincial Order of Pharmacists, General Practitioners, Pediatricians, Farmindustria, Association of ISF, ASL, Doctors employed by the NHS) with tasks of verification, identification of irregularities and application of sanctions
PHARMACOVIGILANCE: ISFs can report any adverse reactions they become aware of to the A-SUR/Territorial Zone
FREE SAMPLES:
< 18 MONTHS: 2/visit max 8/year;
> 18 months: 4/visit max 10/year
❖ Band C: same limits as medicines reimbursable by the NHS
GIFTS: negligible value 25.82 euros/doctor/year. Texts, scientific journals of higher value only in favor of the Operative Units, group medicines/territorial associations. In this case, the pharmaceutical company is required to notify the competent company management.
INFORMATION MATERIAL: only the one approved by AIFA was used
CONFERENCES AND CONGRESSES: doctors communicate their participation to the AO and ASL they belong to
REGION
ACCREDITATION: card supplied by pharmaceutical companies and endorsed by the Region
SSR STRUCTURES: suitable premises, individual visits preferably by appointment or collegiate visits in time slots agreed by the Managements themselves or department manager/operating unit
GP/PLS: visits at specific times according to methods agreed with the doctor
VISITS: approximately 5/year/doctor
AREA HEAD (or other professional figures): coaching for functions other than scientific information
DATA TRANSMISSION: yearly (January 31st) with average annual number of visits Transmission of any change to the list of names communicated within 30 days to the following certified email address: Regionemolise@cert.regione.molise.it
MONITORING TABLE: doctors, pharmacists, institutions, ISF have the task of verifying, identifying irregularities and applying sanctions PHARMACY ACTIVITIES: commercial activity prohibited. It is forbidden to ask for information on prescriptive habits
PHARMACOVIGILANCE: fulfilments in accordance with Legislative Decree of 30 April 2015
FREE SAMPLES: art. 125. Range C without limits
GIFTS: negligible value
INFORMATION MATERIAL: articles 121 and 122 Legislative Decree 219/06
CONFERENCES AND CONGRESSES: both the company and the doctor communicate their participation in the structure to which they belong
REGION
ACCREDITATION: card provided by pharmaceutical companies
MMG/PLS: dedicated time slots
SSR STRUCTURES: suitable premises and dedicated time slots
AREA MANAGER: only in the first 12 months of activity or for specific reasons
DATA TRANSMISSION: annual (January 31st) to the following address: comunica.isf@regione.piemonte.it INFORMATION MATERIAL: articles 121 and 122 Legislative Decree 219/06
FREE SAMPLES: art. 125 Legislative Decree 219/06
PHARMACY ACTIVITIES: as per interregional guidelines.
CONFERENCES AND CONGRESSES: The conferences or congresses concerning medicines are governed by the rules established by art. 124 of Legislative Decree 219/2006.
REGION
ACCREDITATION: card provided by the Pharmaceutical Companies and authenticated by the Region.
SSR STRUCTURES: suitable premises, individual visits preferably by appointment or collegial visits at times agreed by the Managements themselves or department manager/operating unit
GP/PLS: visits at specific times according to methods agreed with the doctor
VISITS: 5/year/doctor
AREA HEAD (or other professional figures): support for functions other than scientific information
ACTIVITY IN PHARMACY: commercial activity prohibited. It is forbidden to ask for information on prescriptive habits
DATA TRANSMISSION: every six months (31 January and 31 July) with the average annual number of visits. Transmission of any change in the list of names communicated within 30 days to the following address: farmaceutica.regione@pec.rupar.puglia.it
MONITORING TABLE: (Representative of the Provincial Order of Doctors, Provincial Order of Pharmacists, General Practitioners, Pediatricians, Association of ISF, ASL, Doctors employed by the NHS) with tasks of verification, identification of irregularities and application of sanctions
PHARMACOVIGILANCE: the ISF must transmit to the USL every single adverse drug reaction of which they become aware
FREE SAMPLES:
< 18 MONTHS: 2/visit max 8/year > 18 months: 4/visit max 10/year ❖ Band C: unlimited
GIFTS: negligible value 20 euros/doctor/year. Texts, scientific journals of higher value only in favor of ASL/AO. For general practitioners and paediatricians of free choice, the transfer is carried out at the district of competence, unless otherwise agreed between contracted doctors and the health company.
INFORMATION MATERIAL: only those approved by AIFA were used
CONFERENCES AND CONGRESSES: pharmaceutical and healthcare companies communicate their participation to the structure they belong to
FOGGIA POLICLINIC
Adoption of Regulations for scientific information on drugs and medical devices (sanita.puglia.it)
ACCREDITATION: remote request to protocol@pec.ospedaliriunitifoggia.it
CARD: supplied by Pharmaceutical Companies
VISITS: maximum 5/year/doctor; suitable premises; agreed time slots; On appointment
CONFERENCES AND CONGRESSES: pharmaceutical and healthcare companies communicate their participation to the structure[1] they belong to
FREE SAMPLES: as per art. 125 Legislative Decree. 219/2006
GIFTS OF NEGLEGLECT VALUE: as per art. 123 Legislative Decree. 219/2006; maximum €20/doctor/year
PHARMACY ACTIVITIES: it is not allowed to provide prescriptive indications to the ISF ACCESS LOG: set up
REGION
RESOLUTION NO. 51/21 OF 12.18.2019
ACCREDITATION: the identification card authenticated by the Department of Hygiene and Health and Social Assistance, on the basis of the lists of names provided by the respective pharmaceutical companies and delivered by them to each ISF. Furthermore, the request for release/certification of the card, the rectification of any of the elements of the authorization and any other communications must be sent exclusively through the One-Stop Service Desk (SUS) of the Region (at the address: https://sus. region.sardegna.it/sus )
SSR STRUCTURES: suitable premises, visits in time slots agreed by the Managements themselves or the manager of the operating unit. Scientific information in hospitals and outpatient clinics must preferably be carried out with meetings involving several operators and can be implemented in forms of public presentation through the creation of scientific information seminars, to be held within the structures, open to the participation of hospital/outpatient doctors and contracted doctors. Other forms of information experimentation aimed at groups of doctors could also be implemented in the field of general medicine
GP/PLS: preferably at times other than the assistance activity
PHARMACY ACTIVITIES: The ISF cannot carry out any commercial activity at pharmacies, both hospital and open to the public (affiliated), such as e.g. direct sale of medicines, collection of medicine orders and transmission to the company's commercial department, acquisition of information about the conditions of sale in the case of direct purchase of medicines
DATA TRANSMISSION: Transmission of any change to the list of names communicated within 30 days to the following address: san.dgsan6@regione.sardegna.it
FREE SAMPLES:
< 18 MONTHS: max 8/year > 18 months: max 10/year
GIFTS: negligible value 20 euros/doctor/year. Texts, scientific journals of higher value only in favor of ASL/AO. In this case the pharmaceutical company must notify the company management of the gifts being distributed.
INFORMATION MATERIAL: only the one approved by AIFA was used
CONFERENCES AND CONGRESSES: pharmaceutical companies, also through the ISF, willing to finance the costs of participation of employees in courses, conferences, congresses or other initiatives must formalize this intention with a written communication, addressed to the General Management of the reference Company, containing the data required by the resolution
TO SASSARI
ACCREDITATION: card provided by the Pharmaceutical Companies
VISITS: collective or individual meetings by appointment, preferably multidisciplinary. Suitable premises and dedicated time slots PHARMACY ACTIVITIES: it is forbidden to provide data by health professionals
REGION
ACCREDITATION: identification card issued by Pharmaceutical Companies. SSR STRUCTURES: suitable premises and agreed reception methods.
GP/PLS: visits at specific times according to methods agreed with the doctor
PHARMACISTS: advertising to local pharmacists of medicines that can be sold on presentation of a medical prescription is limited to the information contained in the summary of the characteristics of the medicine.
For medicines that can be sold without a prescription, advertising may include other useful documentation to allow the pharmacist to provide the customer with advice on the use of the medicine
VISITS: 5/year/doctor
AREA MANAGER (or other professional figures): coaching for functions other than scientific information
PHARMACY ACTIVITIES: commercial activity prohibited. It is forbidden to ask for information on prescriptive habits
DATA TRANSMISSION: yearly (January 31st). Transmission of any change to the list of names communicated within 30 days
MONITORING TABLE: (Representative of the Provincial Order of Doctors, Provincial Order of Pharmacists, General Practitioners, Pediatricians, Association of ISF, ASL, Doctors employed by the NHS) with tasks of verification, identification of irregularities and application of sanctions
FREE SAMPLES:
< 18 MONTHS: 2/visit max 8/year
> 18 months: 4/visit max 10/year
❖ Band C: same limits as medicines reimbursable by the NHS
GIFTS: negligible value
AO GARIBALDI (CT) - RESOLUTION 309/2019
ACCREDITATION: regional.
VISITS: collegial or individual meetings by appointment, preferably multidisciplinary. Suitable premises and dedicated time slots ACCESS LOG: set up
PHARMACY ACTIVITIES: health professionals cannot provide information nor can ISFs ask for it
AREA HEAD (or other professional figures): only for functions other than scientific information
ARNAS OF Cristina Benfratelli (PA) REG 07/08/2019
ACCREDITATION: regional card.
VISITS: collegial or individual meetings by appointment; max 5/year/doctor except for exceptions. Suitable premises and dedicated time slots request an appointment by email from the clinician
ACCESS LOG: set up
PHARMACY ACTIVITIES: it is forbidden to provide data by health professionals and to request data from the ISF AREA HEAD (or other professional figures): only for functions other than scientific information SUBSCRIPTION TO SCIENTIFIC JOURNALS: can only be transferred to operational units
ASP MESSINA
RESOLUTION no. 1855/D4 13/07/2019
ACCREDITATION: regional card.
VISITS: max 5/year/doctor; collegial or individual meetings by appointment in suitable premises and dedicated time slots. In the case of multidisciplinary meetings, the appropriate company form must be completed. ACCESS LOG: set up
FREE SAMPLES: art. 125 Legislative Decree 219/06 < 18 MONTHS: 2/visit max 8/year
> 18 months: 4/visit max 10/year
AO PAPARDO
ACCREDITATION: regional card
VISITS: individual by appointment or collegial. Suitable premises and dedicated time slots
FREE SAMPLES: article 125
AREA HEAD (or other professional figures): only for functions other than medical-scientific information SUBSCRIPTION TO SCIENTIFIC JOURNALS: they can only be transferred to Operational Units
TO CAREGGI (FI)
ACCREDITATION: from 1 August 2021, online request to the Pharmacy Unit by filling in a specific form on the AO website; following acceptance, an identification card is required.
VISITS: individual meeting by appointment with the professional; visits to professionals in the spaces, days and times indicated; collegiate meetings organized by the heads of the departments; suitable premises and dedicated time slots shown on the sign «M/903/D83-C-IS Reception Mode»
REGISTER: established (paper or computerized) FREE SAMPLES: art. 13 Legislative Decree No. 541/92
ACTIVITY IN THE PHARMACY: the pharmacist and the doctor cannot provide information on prescribing habits. Possibility of organizing multidisciplinary meetings involving several professionals.
AUSL NORTH WEST TUSCANY
ACCREDITATION: IS activity allowed in the individual operating units, in identified premises, according to specific times. The IS is allowed only to IS accredited annually by the AUSL.
CARD: The IS accredited are equipped, by the AUSL, with an identification card which must be kept by the IS on computer support, or printed on paper and made available during the activity carried out.
PHARMACY ACTIVITIES: SIs are not allowed to promote commercial activities at the hospital and local AUSL pharmaceutical facilities; request information on the prescribing habits of doctors/dentists; request information on the internal consumption of the health structures of the AUSL.
ACCESS LOG: set up. The employer of the IS (COMPANY) sends a PEC to direzione.uslnordovest@postacert.toscana.it with which he requests the possibility of accessing the structures and communicates the name or list of his employees to be profiled as Company Operators, by filling in a specific excel sheet provided by AUSL. The Company (employer of the SI) registers the Informant on the website. The accredited IS accesses a front-end form and downloads their card which can be printed in PDF (or kept on the smartphone). Each authorization is valid for one year from the date of issue.
AOU PISANA
ACCREDITATION: The relative request must be sent to the UO DMP by completing the T01 form, filled in and signed in the manner and within the foreseen times.
The companies are required to communicate all the identification data of the professionals for whom accreditation is requested (name, surname, CV, contractual status), the copy of the certificate of registration with the chamber of commerce, etc. To the Medical Management Unit which, after an initial evaluation, sends it to the IMS/SP Board of Directors. The authorization takes place with a different bureaucratic process depending on whether it is: variation of the list of IMS-SPs authorized for «termination», for «new entry» or access of the SP «in urgency».
VISITS: Individual, by appointment with the professionals. The meetings with the IMSs must take place at a suitable time identified by each UO/SD, provided that it does not interfere with ordinary institutional activities. Under no circumstances may visits take place within the care areas, in specialist outpatient clinics during visiting hours and in such a way as to hinder the care activity carried out.
SP ACTIVITIES: SPs must have and wear an identification card with the required information. The activity of the SP must take place outside the doctor-patient relationship, although the same may be authorized to attend medical-surgical procedures or check-ups (subject to the patient's consent) and with the sole purpose of supervising the various technical aspects related to the correct application of the device/aid within his competence.
GIFTS: Article 125 of Legislative Decree 219/2006 applies. The doctor who has received/requested the samples is directly responsible for their management, correct conservation and regular disposal.
ACCREDITATION: form filling. Registration request (attachment 1), ISF list and other professional figures (attachment 2); identification card facsimile
VISITS: individual, preferably collegial out of hours dedicated to assistance activities
PROVINCE DETERMINES 127/2016
ACCREDITATION: excel sheet + declaration of the legal representative indicating the scientific manager on whom the ISF depend APSS STRUCTURES: 4 visits/year to suitable premises;
GP/PLS: dedicated time slots
CONFERENCES AND CONGRESSES: non-nominative invitation to the Director of the Operating Unit
DATA TRANSMISSION: annual (January 31) at: serviziofarmaceutico@apss.tn.it. AREA HEAD: only for ISF with no experience
INFORMATION MATERIAL: articles 119 and 120 Legislative Decree 219/06
FREE SAMPLES: art. 125 Legislative Decree 219/06.
PHARMACY ACTIVITIES: health professionals cannot provide information
GIFTS: those exceeding the negligible value must be communicated to an APSS Commission; SURVEILLANCE: sanctions up to the suspension of scientific information from 1 to 12 months.
REGION
ACCREDITATION: card issued annually by the Region
SSR STRUCTURES: suitable premises, visits in time slots agreed by the Managements themselves
GPs/PLS: visits at special times
VISITS (GP/PLS and SSR structures): maximum 5 visits/year/doctor for a maximum of 15 ISF accesses/week
DATA TRANSMISSION: annual (January 31st) with average visits made. Transmission of any change in the list of names promptly communicated.
MONITORING TABLE: the Health Departments have the task of verifying, identifying irregularities and applying sanctions FREE SAMPLES: transfer in compliance with the provisions of art. 13 of Legislative Decree 541/92
INFORMATION MATERIAL: only those approved by AIFA were used. The pharmaceutical company sends the information material to the healthcare providers at the same time as the disclosure begins
REGION
ACCREDITATION: identification card issued by Pharmaceutical Companies; SSR STRUCTURES: suitable places and pre-established times
GP/PLS: no access priority for ISFs
AREA HEAD: only for the first 12 months of activity of the ISFs
DATA TRANSMISSION: yearly (January 31) sanita_politichesociali@pec.regione.vda.it
INFORMATION MATERIAL: articles 119 and 120 Legislative Decree 219/06 FREE SAMPLES: art. 125 Legislative Decree 219/06
CONFERENCES AND CONGRESSES: art. 124 Legislative Decree 219/06
PHARMACY ACTIVITIES: health professionals cannot provide information
VENETO
REGION
ACCREDITATION: card provided by the pharmaceutical company and authenticated by the Region SSR STRUCTURES: suitable premises and agreed time slots
VISITS: 5/year
AREA HEAD or other figures: only for functions other than scientific information
CONFERENCES AND CONGRESSES: health professionals communicate their participation in the structure they belong to DATA TRANSMISSION: yearly (January 31st) to the following address: pec. area.sanitasociale@pec.regione.veneto.it FREE SAMPLES: art. 125 Legislative Decree 219/06
PHARMACY ACTIVITIES: as per regional guidelines
MONITORING TABLE: doctors, pharmacists, institutions, ISF.
ASL Euganean
Circular 138701/2018
Following a check on the application of Regional Resolution 1307/2007, it is recalled that the application of the Resolution must be punctual both in the offices of doctors with an agreement and in the structures of the Regional Health Service.
Source: Egualia. Regional monitoring sheets - SUMMARY REPORT OF REGIONAL RESOLUTIONS - JUNE 2023
Note: All regional regulations prohibit coaching the ISF in any capacity. It is admitted only and solely for training for new hires no later than 12 months from the date of hiring. The ISF also they cannot in any way carry out commercial activities
Related news: Guidelines for the regional regulation of scientific information on drugs
Fedaisf. Laws, regulations in force, sentences
Legislative Decree 24 April 2006, n. 219
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001