MVO Portugal is a non-profit private association, established on 4 August 2017 by the following entities:
- APIFARMA – Associação Portuguesa da Indústria Farmacêutica
- APOGEN – Associação Portuguesa de Medicamentos Genéricos e Biossimilares
- APIEM – Associação Portuguesa de Importadores e Exportadores de Medicamentos
- ADIFA – Associação de Distribuidores Farmacêuticos
- GROQUIFAR – Associação de Grossistas de Produtos Químicos e Farmacêuticos
- AFP – Associação de Farmácias de Portugal
- ANF – Associação Nacional de Farmácias
The aforementioned entities are Permanent Members of MVO Portugal.
MVO Portugal is responsible for the implementation and operation of the national medicines verification system, pursuant to the provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001, amended by Directive 2011/62/EU of the European Parliament and of the Council, of 8 June 2001 and by the Delegated Regulation (EU) 2016/161 of 2 October 2015 Commission. Following the publication of the Delegated Regulation, Decree-Law no. 26/2018, of 24 April was published, transposing the European legislation into the national legal system.
More specifically, MVO Portugal’s responsibilities are as follows (article 4 of the Statutes):
- To apply the requirements set out by EMVO and ensure the general quality of the System’s operation, namely data clean up, the System’s availability and responsiveness and the appropriate security level;
- To set out the terms and conditions of access to the System, which should be practical and transparent;
- To set out and implement the necessary requirements and procedures for the regular operation of the System, including the identification and settlement of any irregularities;
- To hire one or more accredited providers of Information and Communication Technology Services (hereinafter referred to as “ICT Services”) to install and manage the System;
- To hire the required employees and suppliers to pursue its goal;
- To prepare and manage the agreements to use the System and set out the provisions regarding remunerations and methods of payment, taking into account article 31 of the Delegated Regulation and what has been agreed among the Permanent Members;
- To guarantee the communication with the national regulatory authorities on the use of the System to facilitate the procedures of recalling medicinal products and manage other issues regarding the patients’ safety;
- To prepare and provide the members and the Advisory Board with regular activity reports and statistical reports on the System’s operation and performance;
- To carry out periodical strategic assessments to the System to guarantee it progresses over time, in the interest of patient safety and in line with the evolution of the healthcare infrastructure in Portugal and in Europe;
- To invoice and to collect fees, and other participation fees and costs, according to the Directive and the Delegated Regulation and any other amounts owed by the members in terms of the statutes.
More information on MVO Portugal can be found here.
MVO Portugal’s corporate bodies
The corporate bodies for the two-year period of 2018/2019 are the following:
- General Meeting:
- President – APOGEN – Maria do Carmo Neves
- Pharmacies – AFP – Manuela Pacheco
- APIFARMA – Pedro Caridade de Freitas
- Board of Directors:
- President – APIFARMA – João Almeida Lopes
- Vice-President – APOGEN – Paulo Lilaia
- APIEM – António Mendonça Alves
- ADIFA – Tiago Galvão Alves Pereira
- ANF – Pedro Ferreira
- APIFARMA – Cristina Lopes
- APIFARMA – Joaquim Chaves
- Supervisory board:
- President – GROQUIFAR – Tiago Seguro
- APIEM – João Esteves
- PKF & Associados, SROC, Lda., SROC number 152, with registered office at Praça Duque de Saldanha, no. 1, 4, H and O, in Lisbon, corporate body number 504.046.683, represented by Paulo Jorge Macedo Gambôa, ROC no. 1068
MVO Portugal’s team
MVO Portugal’s team is composed of elements with relevant experience in the pharmaceutical sector and in implementing large and complex IT projects.
The following persons are part of the team:
- Ricardo Valente, General Manager (firstname.lastname@example.org);
- Nuno Lages, Quality Assurance Manager (email@example.com);
- José Pedro Fernandes, IT Operations Manager (firstname.lastname@example.org);
- Teresa Pimenta Teixeira, Office Manager (email@example.com).
The financing of MVO Portugal
MVO Portugal’s activity is financed through the amounts paid by the Marketing Authorization or Parallel Import Authorization holders and by its Permanent Members (APIFARMA, APOGEN, APIEM, ADIFA, GROQUIFAR, AFP and ANF), according to the model approved by the General Meeting.
The model for determining the fees for the Marketing Authorization or Parallel Import Authorization holders’ participation, in force for 2018, is the following:
Up to 10 authorisations
Sales up to (and including) 1.000.000 EUR per year, per authorisation
1.000 EUR + VAT per authorisation
Up to 10 authorisations
Sales above 1.000.000 EUR per year, per authorisation
10.000 EUR + VAT
More than 10 authorisations
10.000 EUR + VAT
In addition to the table above:
- By “authorisation” is meant the Marketing Authorization or Parallel Import Authorization granted by the competent authorities. For fee calculation purposes, the authorisation corresponds to the registration number;
- Only the authorizations with status “authorized” will be considered for fee calculation purposes;
- Only the authorizations whose products are marketed will be considered for fee calculation purposes;
- Only the products under the scope of the Delegated Regulation and national applicable legislation (if any) will be considered for fee calculation purposes;
- A single annual payment will apply, from 2018 onwards;
- No further costs shall be due apart from those referred to above;
- VAT shall be applied at the rate in force on the invoice date.
For representatives of Marketing Authorization or Parallel Import Authorization holders, the annual fee shall be the sum of the application of the formula described above to each Marketing Authorization or Parallel Import Authorization holder they represent.
The first invoice shall be issued on 2018 and, in the following years, the fee shall be due in its entirety on January each year.
The Associations that are a member of MVO Portugal pay an annual lump-sum.
LOCATION AND CONTACTS
MVO Portugal’s registered office is located at the following address:
Avenida Dom Vasco da Gama 34
The above mentioned address shall be taken into consideration for formal documents (i.e., contracts, etc.).
All documents must be sent to MVO Portugal’s offices, located at the following address:
Torre de Monsanto
Rua Afonso Praça 30, 7º
1495-061 – Algés
The telephone number is 211 214 967 and the email address is firstname.lastname@example.org.