The decentralised procedure timetable, explained day by day

The DCP is set out in Article 28(3) to (5) of Directive 2001/83/EC. The applicant submits an identical dossier to every Member State where it wants an authorisation and asks one of them to act as reference Member State (RMS). Within 120 days of receiving a valid application the RMS prepares a draft assessment report, a draft summary of product characteristics (SmPC), labelling and package leaflet, and sends them to the concerned Member States (CMS) and the applicant (Article 28(3)). The CMS then have 90 days to approve those documents (Article 28(4)); once the RMS records the agreement and closes the procedure, each Member State adopts its national decision within 30 days (Article 28(5)).

The directive gives the skeleton. The day-by-day milestones come from the Member States' standard operating procedure for the DCP and the best practice guide for the decentralised and mutual recognition procedures, both published by the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh). The glossary entries on the RMS and the CMS describe the two roles: the RMS assesses and co-ordinates, the CMS comment and must agree, and a CMS can only block the outcome on grounds of a potential serious risk to public health.

The route is open to any product outside the mandatory scope of the centralised procedure in Regulation (EC) No 726/2004. In practice it is the standard route for generics, hybrids and well-established use applications.

The procedure cannot start until the RMS has a slot for it. Each agency sets its own rules for allocating slots and publishes them in the CMDh compilation of national recommendations for requests to act as RMS. Most allocate first come, first served using the common CMDh request form; some want the request two or three months before submission, others accept bookings up to two years ahead. The SOP recommends a pre-submission exchange with the RMS at least two months before submission, and the CMDh publishes recommended submission dates each year so that Day 210 does not fall at a weekend or in a holiday period.

Once submitted to all Member States, the validation period is 14 days and starts when the RMS and every CMS have received a technically valid application. The RMS completes the main validation against its checklist and the CMS limit themselves to the points on the CMS checklist. A positive validation is recorded in the CTS tracking system and the RMS confirms the start of the procedure and the timetable. Common reasons for a delayed Day 0 are an application form that does not match the dossier, missing proof of fee payment in a CMS, legal basis questions and incomplete module 1 documents such as the pharmacovigilance system summary.

Two details of step I surprise first-time applicants. The procedure can close at Day 105: for a straightforward generic with no objections, the assessment ends before any clock-stop and the national step follows. And the applicant may send the RMS a draft response during the clock-stop, so the RMS can flag whether the main concerns are answered before the final response goes to every CMS.

The procedure can close at any point in step II once every CMS agrees the product is approvable; Day 210 is the latest, not the target. At Day 210 the RMS closes a positive procedure with the final assessment report and agreed texts, or closes a negative one if it concludes the product is not approvable, in which case there is no referral and each Member State refuses nationally. If a CMS maintains a potential serious risk to public health at Day 210, the RMS refers the points of disagreement to the CMDh within seven days under Article 29(1) of the directive.

The CMDh then has 60 days to reach agreement (Article 29(3)). If it does, the RMS records the agreement and closes the procedure at Day 270. If it does not, the matter goes to the Committee for Medicinal Products for Human Use for scientific arbitration under Articles 32 to 34, and the Member States that agreed with the RMS may, at the applicant's request, authorise the product without waiting for the outcome (Article 29(6)). The glossary entry on referrals sets out the arbitration route.

Closing the procedure is not the same as holding a licence. Under Article 28(5) each Member State adopts its national decision within 30 days of the RMS recording the agreement. That clock is conditional: the CMDh best practice guide expects the applicant to submit high-quality national translations of the SmPC, leaflet and labelling, with mock-ups where needed, no later than seven calendar days after the procedure closes. Member States may only make linguistic changes to the agreed texts and may add national blue-box information. A late or poor translation is the most common reason the 30 days become 60 or 90, and the product cannot be marketed in that country until the national decision issues.

The national phase is also where the common renewal date is set, usually five years after the end of the procedure. Regunaut Atlas keeps these dates, obligations and fees per product and market on one timeline.

Formally, the clock stops once, at Day 105, and only if there is no consensus. The default response period is three months, which the applicant can extend by a further three months on a justified request sent to the RMS at least one month before the deadline; six months is the ceiling, after which the RMS either restarts the procedure on the information available or asks the applicant to withdraw in all Member States. In practice the time to approval is usually 12 to 18 months from Day 0, and the following issues account for most of the clock-stop time.

• Quality questions on the active substance, in particular an active substance master file whose closed part raises questions that the ASMF holder, not the applicant, must answer within the same period.
• Bioequivalence: the reference product, the study design or a borderline result. The glossary entry on bioequivalence covers the usual objections.
• Divergent national positions on the product information, especially where the reference product's national SmPCs differ.
• User consultation of the package leaflet that was not performed or not bridged.
• Legal basis and data protection: whether the reference product's protection periods have expired in every CMS, and whether the generic or hybrid basis is the right one.
• Orphan similarity, which the applicant must check before submission, during the clock-stop and again in the national phase.

The response should answer each question in order and update every affected module, because the RMS writes the draft assessment report from it between Day 106 and Day 120. New studies are not accepted after that, so the clock-stop is the one place to put complete data in.

The RMS writes the assessment report that every CMS relies on, so the choice shapes the whole procedure. Four practical criteria matter most.

• Slot availability. Agencies differ widely in how far ahead they are booked and how they allocate slots; the CMDh compilation of national recommendations lists each agency's rules and contact points, and some publish free capacity monthly.
• Experience with the product type. An RMS that has assessed the same active substance or dosage form will have settled positions on the product information and on the typical objections, which shortens step I.
• Fees and language. RMS fees are usually higher than CMS fees and vary considerably; the RMS also sets expectations on the language of the response and the quality of the English texts that all CMS translate from.
• The later procedures. The RMS of the DCP is the RMS for every later variation, renewal and repeat-use procedure on the same authorisation, so the agency's performance on variations matters as much as its speed on the initial assessment.

A pre-submission exchange with the intended RMS, at least two months before submission, tests these assumptions and fixes the timetable. Scientific advice on a contentious point, such as a biowaiver or a hybrid legal basis, before the slot is booked avoids spending the clock-stop on it.

The glossary entry on MRP covers the mutual recognition route in more detail. The trade-off is control against coverage: DCP and MRP give one national authorisation per country, which can be varied, renewed or withdrawn market by market, while the centralised route gives a single licence with one product information text for the whole EU. For a generic portfolio the DCP, followed by repeat-use MRP waves, remains the usual pattern.

The agreed 2026 EU pharma package keeps the national procedures, the reference Member State model and the CMDh, and sets the centralised assessment at 180 days instead of 210 in the regulation half of the package. Our overview of the new pharmaceutical regulation covers the centralised changes, and the legislative timeline tracks when the new texts will apply; article numbers and day counts for the national procedures should be checked against the act once it is published in the Official Journal.