Revocation upon renunciation of the marketing authorization can be requested directly from the marketing authorization holder of the medicinal product. There may be several reasons why you request it.
Over the past few months we have repeatedly said that each drug has beneficial properties and side effects. During the period in which the drug is on the market, it may happen that it undergoes modifications, revocations, renewals, extensions of the MA and withdrawals from the market. [on the right definition of medicine from art. 1 Legislative Decree 219/96]
Ohga - February 2, 2022 - by Chiara Speroni Doctor of pharmacy
Having said that, you must know that there are laws behind it to guarantee the quality, efficacy and safety of the medicine, starting from production, to storage up to transport, dispensing and final consumption by the user.
Now we have to introduce two simple but fundamental concepts which are the authorization for the production of the AP medicinal product and the marketing authorization for the AIC.
AP: Production Authorization
The AP is an authorization issued after a thorough inspection aimed at ascertaining the requirements of the applicant, such as qualified personnel and the necessary technical and industrial means. The manufacturer forwards the request to AIFA reporting the specification of the medicines and pharmaceutical forms it intends to produce. If the outcome is positive, AIFA informs EMEA of the authorization and publishes the updated list of producers in the Official Gazette.
AIC: Marketing Authorisation
The AIC is the authorization to place the medicine produced by the authorized workshop. The authorization is issued by AIFA or EMEA (we don't get lost with the different marketing procedures, you just need to know that it can be at a national level or through authorizations already present in member states of the European community). The manufacturer will have to provide the competent bodies with the data relating to the medicinal products for which he has requested authorization and communicate any modifications or changes to the documents presented, he will also have to take into account scientific and technical progress for the purposes of production and control of the medicinal product. It will be his duty to inform AIFA/EMEA of his possible intention to withdraw the product from the market, or even cease production.
Once the marketing authorization has been obtained, it will be valid for 5 years and can be renewed after a risk/benefit assessment by AIFA/EMEA on the basis of the updated dossier, presented within 6 months of expiry. After this renewal, the AIC obtains unlimited validity.
What is revocation
Revocation upon renunciation by the manufacturer is governed by thearticle 38, paragraph 9 of Legislative Decree 219/2006 and concerns the entire marketing authorization of a medicinal product. The revocation must be signed by the legal representative of the AIC of the product.
There revocation can be ordered in the following cases:
- The medicinal product was found to be harmful under normal conditions of use
- The medicinal product does not achieve the therapeutic effect or effect for which it was authorised
- The risk/benefit ratio under normal conditions of use
- The medicinal product does not have the qualitative and quantitative composition declared in the dossier
- The information in the dossier is incorrect or has not been changed
- When no checks have been carried out on the finished product, components or intermediate products of production
- When the trials presented in support of the marketing authorization request were conducted without respecting the principles and guidelines of the rules of good clinical practice established by Community legislation.
- Commercial reasons
The revocation entails definitive withdrawal of the medicine from the market.
Sources| AIFA; Legislationone Pharmaceuticals – P. Minghetti, M. Marchetti
Note:
Forfeiture of the AIC (Sunset clause)
Any marketing authorization for a medicinal product expires if it is not followed by effective marketing on the national territory within the three years following its release. The authorization also expires when an authorized and marketed medicinal product is no longer actually marketed for three consecutive years in the national territory. The data relating to the lapsed AICs are published in the Official Gazette by AIFA.
In exceptional cases and for public health reasons, the AIFA, with a reasoned provision, can exempt the medicinal product from forfeiture. This exemption is assessed on a case-by-case basis for a medicinal product that meets at least one of the following requirements:
a) Medicinal product for which there is no alternative supplier or alternative treatment, the lack of which could have a negative impact on public health: the exemption from revocation lasts for one year.
b) Medicinal product stored as part of emergency procedures: the exemption from forfeiture has a duration of three years.
Requests for exclusion or exemption from MAs due to non-marketing must be sent to AIFA (subject: SUNSET CLAUSE) to the PEC address: areastrategiaeconomiadelfarmaco@pec.aifa.gov.it
AIFA periodically publishes thelist of the lapsed AICs and notices of imminent expiry.
Authorization revocation upon waiver of the Holder
Authorization Revocations upon renunciation (art. 38, paragraph 9, of Legislative Decree 219/2006) concern the entire marketing authorization of a medicinal product (if the Holder intends to suppress one or more packs of a medicinal product and not the entire AIC the specific procedure is that of the "variation"). For the purpose of issuing the revocation determination, the Holder who intends to renounce the MA must send a written note to the PQ-PhCC Office, attaching:
- €16.00 revenue stamp
- copy of the communication on the same subject sent to the RMS in the case of a medicinal product registered with the MR/DC procedure
The note must be signed by the legal representative of the Marketing Authorization Holder or another person with the powers of representation, or by a prosecutor accredited to AIFA, indicating the e-mail addresses (possibly PEC) necessary for the notification of the provision and any document integration requests. It is not possible to request the revocation of several AICs in a single communication.
Without prejudice to the unquestionable right of the Marketing Authorization Holder to renounce his/her own marketing authorization also for commercial reasons, the PQ-PhCC Office is required to verify first that the revocation of the medicinal product in question does not lead to a state of shortage, due to the unavailability of any similar products on the market. If necessary, the Agency can initiate contacts with the Marketing Authorization Holder in order to evaluate the possibility of adopting specific initiatives aimed at containing or managing emergency situations.
Once the technical and administrative evaluation has been completed, the Agency issues a decision to revoke the MA which is notified to the Holder and sent, by extract, to the Official Gazette for publication, as well as to other public bodies and institutions, to the regional and provincial health care and trade associations. The company is required to indicate in the communication any request for a term for the disposal of stocks, if any. The concession of the stock disposal term, equal to 180 days starting from the date of publication of the provision in the Official Journal, is expressly mentioned in the determination of revocation upon waiver. The deadline cannot be extended, except for public health reasons.
Source AIFA. Modifications, renewals and forfeiture of the AIC
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