Addendum to the Clinical Overview (Addendum, AddCO) included in Module 2.5 of the authorisation dossier provides important data on medicinal product safety and efficacy issues consisting the basis of the application for the renewal of the Marketing Authorisation (MA). The Addendum is required for the renewal of medicinal products in national, centralized and European procedures: in the decentralized procedure (DCP) and in the mutual recognition procedure (MRP). It should be highlighted that AddCO is also usually required for renewal procedures in countries outside the European Union. Beside the renewal procedure, Addendum to the Clinical Overview is also needed for clinical type II variations, e.g. in the process of medicinal product legal status change from Rx to OTC (so called “OTC switch”).
On legal basis of Articles 14(1) of Regulation (EC) No 726/2004 and 24(1) of Directive 2001/83/EC, the Marketing Authorisations are granted for the initial duration of 5 years. After this period, the Marketing Authorisation can be renewed under re-evaluation of the risk-benefit balance. At least 9 months before the MA expiry, the Marketing Authorisation Holder (MAH) needs to submit the application for MA renewal along with required documents including Addendum to the Clinical Overview. The content of the Addendum document is determined by the EMA Guideline on the Processing of Renewals in the Centralised Procedure and CMDh Best Practice Guide on the processing of renewals in the MRP/DCP.
The Addendum should consist of a critical discussion addressing the current benefit/risk balance for the medicinal product based on the consolidated version of safety/efficacy data accumulated since the granting of the initial MA or the last renewal, taking account of PSUR data (if applicable), suspected adverse reaction reports, additional pharmacovigilance activities and the effectiveness of risk minimization measures contained in the Risk Management Plan (RMP). The scope of the assessment covers the date from the first registration or last product registration to the 90 days preceding the submission of the application for renewal of the authorization (so called, data lock point, DLP). Once renewed, the marketing authorisation will be valid for unlimited time (unless Regulatory Agencies decide otherwise).
At SciencePharma, while preparing the Addendum, we take into account the data received from the Client, data from literature review (if performed), data from PSURs (if applicable), and the data on effectiveness of the risk minimization measures included in the RMP. The ready Addendum is submitted to the Client along with the Expert’s CV and Module 1.4.3. The Addendum preparation service is often provided by our Experts in connection with other services, especially medical writing services, monitoring on the safety of medicinal products (Pharmacovigilance, PV) and Rx to OTC legal status change (check our OTC-switch services. We also recommend our article on OTC switch).
We have many years of experience in the preparation of Addendum to the Clinical Overview (AddCO) (for various product categories, formulations, indications). Thanks to this, we know what to pay special attention to when writing Addendum – we conduct the careful assessment of effectiveness of the medicinal product, using all the data sources available, to prove that the advantages of the product outweigh its disadvantages and risks associated with its use. We analyze whether the new safety information (collected over this period) is consistent with the existing information in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL). Due to extensive experience, we know the detailed expectations of individual Regulatory Agencies, thus we are able to efficiently meet the requirements in each country.
By outsourcing the preparation of the Addendum to SciencePharma, the Client receives a quick, comprehensive and reliable elaboration of the topic, which results in the acceleration of the medicinal product renewal process. The documentation prepared by us is always properly adapted to a specific product. We always operate in accordance with the latest guidelines, based on the Good Pharmacovigilance Practices (GVP) standards, current legal regulations and the requirements of Regulatory Agencies. Our Experts are graduates of medical universities, people with higher education in biological studies and related sciences (including doctoral degree). We have a group of regular Customers for whom we write Addendum, but we also provide documentation writing services at individual orders. We provide services to both Polish companies and foreign Clients. We have experience in preparing Addendum not only for products in Poland and the EU, but also outside the EU in accordance with local requirements. We ensure good communication with the Client and adhere to the agreed deadlines.
Interested in Addendum to the Clinical Overview (AddCO) preparation?
Please, contact us.