<?xml version="1.0" encoding="UTF-8"?>
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns:thisfile="me" xmlns:rdm="http://www.ema.eaf/dictionary/" xmlns:maa="http://www.ema.eaf/maa/" targetNamespace="http://www.ema.eaf/maa/" elementFormDefault="qualified" version="1.28.0.0">
	<xs:import namespace="http://www.ema.eaf/dictionary/" schemaLocation="eaf_dictionary.xsd"/>
	<xs:element name="eu_application_form">
		<xs:complexType>
			<xs:sequence>
				<xs:element name="envelope" type="rdm:envelope"/>
				<xs:element name="initial-application-form-human">
					<xs:complexType>
						<xs:sequence>
							<xs:element name="scientific-advice" type="rdm:scientific-advice"/>
							<xs:element name="declaration">
								<xs:complexType>
									<xs:sequence>
										<xs:element name="product-invented-name" type="rdm:string250"/>
										<xs:element name="medicinal-product" type="rdm:medicinal-product" maxOccurs="unbounded"/>
										<xs:element name="active-substances-description" type="xs:string" minOccurs="0"/>
										<xs:element name="active-substances" minOccurs="0">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="active-substances-details" minOccurs="1" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="active-substance-detail" type="xs:string"/>
																<xs:element name="active-substance" type="rdm:ingredient" minOccurs="1" maxOccurs="unbounded"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="applicant" type="rdm:contact-details-type"/>
										<xs:element name="authorised" type="rdm:contact-details-type"/>
										<xs:element name="signature" type="rdm:contact-details-type"/>
										<xs:element name="dec-signature" type="xs:string"/>
										<xs:element name="function" type="xs:string"/>
										<xs:element name="place" type="rdm:string30"/>
										<xs:element name="date" type="xs:date"/>
										<xs:element name="annex5-4" type="rdm:yes-no"/>
										<xs:element name="annex5-1" type="rdm:yes-no"/>
									</xs:sequence>
								</xs:complexType>
							</xs:element>
							<xs:element name="chapter-1">
								<xs:complexType>
									<xs:sequence>
										<xs:element name="procedure-type">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="centralised-procedure" type="rdm:centralised-procedure" minOccurs="0"/>
													<xs:element name="mutual-recognition-procedure" type="rdm:mutual-recognition-procedure" minOccurs="0"/>
													<xs:element name="decentralised-procedure" type="rdm:decentralised-procedure" minOccurs="0"/>
													<xs:element name="national-procedure" type="rdm:national-procedure" minOccurs="0"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="orphan-designation">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="od-medicinal-product">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="od-procedure" type="rdm:od-procedure" minOccurs="0" maxOccurs="unbounded"/>
																<xs:element name="legislation" type="rdm:legislation" minOccurs="0" maxOccurs="unbounded"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="od-market-exclusivity" type="rdm:od-market-exclusivity"/>
												</xs:sequence>
												<xs:attribute name="is_significant-benefit">
													<xs:annotation>
														<xs:documentation>text choice(“yes” | “no”| “null”)</xs:documentation>
													</xs:annotation>
												</xs:attribute>
											</xs:complexType>
										</xs:element>
										<xs:element name="change-market-authorization">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="yes" type="rdm:yes-no"/>
													<xs:element name="specify-yes" type="rdm:radiobutton"/>
													<xs:element name="qualitative-change" type="rdm:yes-no"/>
													<xs:element name="qualitative-change-detail" type="rdm:radiobutton"/>
													<xs:element name="bioavailability" type="rdm:yes-no"/>
													<xs:element name="pharmacokinetics" type="rdm:yes-no"/>
													<xs:element name="strength-potency" type="rdm:yes-no"/>
													<xs:element name="pharma-form" type="rdm:yes-no"/>
													<xs:element name="route-of-admin" type="rdm:yes-no"/>
													<xs:element name="article-29" type="rdm:yes-no"/>
													<xs:element name="authorisation-new-pharma-form" type="rdm:yes-no"/>
													<xs:element name="authorisation-new-route-of-admin" type="rdm:yes-no"/>
													<xs:element name="product" type="rdm:product-type" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="directive-2001-83-ec">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="section1-4-1">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="article-8-3" type="rdm:yes-no"/>
																<!-- <xs:element name="new-active-substance" type="rdm:yes-no"/> -->
																<!-- <xs:element name="known-active-substance" type="rdm:yes-no"/> -->
																<!-- <xs:element name="attach-letter" type="rdm:yes-no"/> -->
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="generic-application">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="article-10-1" type="rdm:yes-no"/>
																<xs:element name="reference-medicinal-products">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="first-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="reference-medicinal-product" type="rdm:reference-medicinal-product-type" maxOccurs="unbounded"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																			<xs:element name="second-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="reference-medicinal-product" type="rdm:reference-medicinal-product-type" maxOccurs="unbounded"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																			<xs:element name="third-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="bio-reference-medicinal-product" type="rdm:bio-reference-medicinal-product" maxOccurs="unbounded"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="hybrid-application">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="reference-medicinal-products">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="article10-3" type="rdm:yes-no"/>
																			<xs:element name="first-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="reference-medicinal-product" type="rdm:reference-medicinal-product-type" maxOccurs="unbounded"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																			<xs:element name="second-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="reference-medicinal-product" type="rdm:reference-medicinal-product-type" maxOccurs="unbounded"/>
																						<xs:element name="change-active-substance" type="rdm:yes-no"/>
																						<xs:element name="change-therapeutic-indication" type="rdm:yes-no"/>
																						<xs:element name="change-strength" type="rdm:yes-no"/>
																						<xs:element name="change-addition" type="rdm:yes-no"/>
																						<xs:element name="route-admin" type="rdm:yes-no"/>
																						<xs:element name="bioavailability" type="rdm:yes-no"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																			<xs:element name="third-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="bio-reference-medicinal-product" type="rdm:bio-reference-medicinal-product" maxOccurs="unbounded"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="similar-application">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="article-10-4" type="rdm:yes-no"/>
																<xs:element name="reference-medicinal-products">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="first-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="reference-medicinal-product" type="rdm:reference-medicinal-product-type" maxOccurs="unbounded"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																			<xs:element name="second-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="reference-medicinal-product" type="rdm:reference-medicinal-product-type" maxOccurs="unbounded"/>
																						<xs:element name="change-raw-substance" type="rdm:yes-no"/>
																						<xs:element name="change-therapeutic-indication" type="rdm:yes-no"/>
																						<xs:element name="change-strength" type="rdm:yes-no"/>
																						<xs:element name="change-addition" type="rdm:yes-no"/>
																						<xs:element name="route-admin" type="rdm:yes-no"/>
																						<xs:element name="manufacturing" type="rdm:yes-no"/>
																						<xs:element name="other" type="rdm:yes-no"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																			<xs:element name="third-rmp">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="reference-medicinal-product" type="rdm:reference-medicinal-product-type" maxOccurs="unbounded"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="section1-4-5" type="rdm:yes-no"/>
													<xs:element name="section1-4-6" type="rdm:yes-no"/>
													<xs:element name="section1-4-7">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="selected" type="rdm:yes-no"/>
																<xs:element name="attach-letter" type="rdm:yes-no"/>
																<xs:element name="products">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="product" type="rdm:product-type" maxOccurs="unbounded"/>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="section1-4-8" type="rdm:yes-no"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="section1-5">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="section1-5-1" type="rdm:yes-no"/>
													<xs:element name="section1-5-2" type="rdm:yes-no"/>
													<xs:element name="section1-5-3">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="accelerated-review" type="rdm:yes-no"/>
																<xs:element name="chmp" type="xs:date"/>
																<xs:element name="chmp-details" type="xs:string"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="section1-5-4" type="rdm:yes-no"/>
													<xs:element name="section1-5-5" type="rdm:yes-no"/>
													<xs:element name="section1-5-6" type="rdm:yes-no"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="section1-6">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="section-decision" type="rdm:yes-no"/>
													<xs:element name="section-same-active-substance">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="yes-no" type="rdm:yes-no"/>
																<xs:element name="products">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="medproduct" maxOccurs="unbounded">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="product" type="rdm:product-type" maxOccurs="unbounded"/>
																						<xs:element name="supplementary-protection-certificate">
																							<xs:complexType>
																								<xs:sequence>
																									<xs:element name="scp" type="rdm:yes-no"/>
																									<xs:element name="scp-qualify" type="rdm:yes-no"/>
																								</xs:sequence>
																							</xs:complexType>
																						</xs:element>
																						<xs:element name="member-state" type="xs:string"/>
																						<xs:element name="active-substances">
																							<xs:complexType>
																								<xs:sequence>
																									<xs:element name="active-substance" type="rdm:ingredient" minOccurs="1" maxOccurs="unbounded"/>
																								</xs:sequence>
																							</xs:complexType>
																						</xs:element>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="section-new-indication">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="new-indication" type="rdm:yes-no"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="section-application-process">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="decision" type="rdm:decision"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="section-puma">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="article-30" type="rdm:yes-no"/>
																<xs:element name="not-protected-by-supplementary" type="rdm:yes-no"/>
																<xs:element name="pip-decision-nums">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="decision-number" maxOccurs="unbounded">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="number" type="rdm:string30"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="section-complaince-verification">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="yes" type="rdm:yes-no"/>
																<xs:element name="compliance-document-references" maxOccurs="unbounded">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="reference" type="rdm:string30"/>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
																<xs:element name="procedure-nums">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="proc-num" maxOccurs="unbounded">
																				<xs:complexType>
																					<xs:sequence>
																						<xs:element name="number" type="rdm:string30"/>
																					</xs:sequence>
																				</xs:complexType>
																			</xs:element>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="section1-7">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="prime-decision" type="rdm:yes-no"/>
													<xs:element name="prime-number" type="rdm:string500"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
									</xs:sequence>
								</xs:complexType>
							</xs:element>
							<xs:element name="chapter-2">
								<xs:complexType>
									<xs:sequence>
										<xs:element name="medicinal-product" type="rdm:medicinal-product" maxOccurs="unbounded"/>
										<xs:element name="annex5-19" type="rdm:yes-no"/>
										<xs:element name="active-substances">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="active-substance" type="rdm:ingredient" minOccurs="1" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="substanceType" type="rdm:control-term"/>
										<xs:element name="new-active-substance" type="rdm:yes-no"/>
										<xs:element name="known-active-substance" type="rdm:yes-no"/>
										<xs:element name="attach-letter" type="rdm:yes-no"/>
										<xs:element name="annex5-17" type="rdm:yes-no"/>
										
										<xs:element name="Medical-devices">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="Med-devices-checkboxes" maxOccurs="unbounded">
													<xs:complexType>
														<xs:sequence>
															<xs:element name="Med-devices-checkbox-a" type="rdm:yes-no"/>
															<xs:element name="Med-devices-subSections-a" maxOccurs="unbounded">
															<xs:complexType>
															<xs:sequence>
															<!-- 2.2.4.1 -->
															<xs:element name="Device-name" type="xs:string"/>
															<xs:element name="Device-description" type="xs:string"/>
															<xs:element name="Device-purpose" type="xs:string"/>
															<xs:element name="Device-classification" type="rdm:radiobutton"/>
															<xs:element name="Device-serial-no" type="xs:string"/>
															<xs:element name="sterile" type="rdm:yes-no"/>
															<xs:element name="measuring_function" type="rdm:yes-no"/>
															<xs:element name="reusable" type="rdm:yes-no"/>
															<!-- 2.2.4.2 -->
															<xs:element name="Device-manufacturer" type="rdm:radiobutton"/>
															<xs:element name="Manufacture-contact-details" type="rdm:contact-details-type"/>
															<!-- 2.2.4.3 -->
															<xs:element name="confirm-compliance" type="rdm:yes-no"/>
															<xs:element name="explain-no" type="xs:string"/>
															<xs:element name="specify-yes" type="rdm:radiobutton"/>
															<!-- 2.2.4.4 -->
															<xs:element name="Contact-details">
																	<xs:complexType>
																		<xs:complexContent>
																			<xs:extension base="rdm:contact-details-type">
																				<xs:sequence>
																					<xs:element name="Telephone" type="xs:string"/>
																					<xs:element name="Email" type="xs:string"/>
																					<xs:element name="Number" type="xs:string"/>
																				</xs:sequence>
																			</xs:extension>
																		</xs:complexContent>
																	</xs:complexType>
															</xs:element>														
														</xs:sequence>
													</xs:complexType>
													</xs:element>
													<xs:element name="Med-devices-checkbox-b" type="rdm:yes-no"/>
													<xs:element name="Med-devices-subSections-b" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
															<!-- 2.2.4.1 -->
															<xs:element name="Device-name" type="xs:string"/>
															<xs:element name="Device-description" type="xs:string"/>
															<xs:element name="Device-purpose" type="xs:string"/>
															<xs:element name="Device-classification" type="rdm:radiobutton"/>
															<xs:element name="Device-serial-no" type="xs:string"/>
															<xs:element name="sterile" type="rdm:yes-no"/>
															<xs:element name="measuring_function" type="rdm:yes-no"/>
															<xs:element name="reusable" type="rdm:yes-no"/>
															<!-- 2.2.4.2 -->
															<xs:element name="Device-manufacturer" type="rdm:radiobutton"/>
															<xs:element name="Manufacture-contact-details" type="rdm:contact-details-type"/>
															<!-- 2.2.4.3 -->
															<xs:element name="confirm-compliance" type="rdm:yes-no"/>
															<xs:element name="explain-no" type="xs:string"/>
															<xs:element name="specify-yes" type="rdm:radiobutton"/>
															<!-- 2.2.4.4 -->
															<xs:element name="Contact-details">
																	<xs:complexType>
																		<xs:complexContent>
																			<xs:extension base="rdm:contact-details-type">
																				<xs:sequence>
																					<xs:element name="Telephone" type="xs:string"/>
																					<xs:element name="Email" type="xs:string"/>
																					<xs:element name="Number" type="xs:string"/>
																				</xs:sequence>
																			</xs:extension>
																		</xs:complexContent>
																	</xs:complexType>
															</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
														
													<xs:element name="Med-devices-checkbox-c" type="rdm:yes-no"/>
													<xs:element name="Med-devices-subSections-c" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
															<!-- 2.2.4.1 -->
															<xs:element name="Device-name" type="xs:string"/>
															<xs:element name="Device-description" type="xs:string"/>
															<xs:element name="Device-purpose" type="xs:string"/>
															<xs:element name="Device-classification" type="rdm:radiobutton"/>
															<xs:element name="Device-serial-no" type="xs:string"/>
															<xs:element name="sterile" type="rdm:yes-no"/>
															<xs:element name="measuring_function" type="rdm:yes-no"/>
															<xs:element name="reusable" type="rdm:yes-no"/>
															<!-- 2.2.4.2 -->
															<xs:element name="Device-manufacturer" type="rdm:radiobutton"/>
															<xs:element name="Manufacture-contact-details" type="rdm:contact-details-type"/>
															<!-- 2.2.4.3 -->
															<xs:element name="confirm-compliance" type="rdm:yes-no"/>
															<xs:element name="explain-no" type="xs:string"/>
															<xs:element name="specify-yes" type="rdm:radiobutton"/>
															<!-- 2.2.4.4 -->
															<xs:element name="Contact-details">
																	<xs:complexType>
																		<xs:complexContent>
																			<xs:extension base="rdm:contact-details-type">
																				<xs:sequence>
																					<xs:element name="Telephone" type="xs:string"/>
																					<xs:element name="Email" type="xs:string"/>
																					<xs:element name="Number" type="xs:string"/>
																				</xs:sequence>
																			</xs:extension>
																		</xs:complexContent>
																	</xs:complexType>
															</xs:element>														
															</xs:sequence>
														</xs:complexType>
													</xs:element>
															
													<xs:element name="Med-devices-checkbox-d" type="rdm:yes-no"/>
													<xs:element name="Med-devices-subSections-d" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
															<!-- 2.2.4.1 -->
															<xs:element name="Device-name" type="xs:string"/>
															<xs:element name="Device-description" type="xs:string"/>
															<xs:element name="Device-purpose" type="xs:string"/>
															<xs:element name="Device-classification" type="rdm:radiobutton"/>
															<xs:element name="Device-serial-no" type="xs:string"/>
															<xs:element name="sterile" type="rdm:yes-no"/>
															<xs:element name="measuring_function" type="rdm:yes-no"/>
															<xs:element name="reusable" type="rdm:yes-no"/>
															<!-- 2.2.4.2 -->
															<xs:element name="Device-manufacturer" type="rdm:radiobutton"/>
															<xs:element name="Manufacture-contact-details" type="rdm:contact-details-type"/>
															<!-- 2.2.4.3 -->
															<xs:element name="confirm-compliance" type="rdm:yes-no"/>
															<xs:element name="explain-no" type="xs:string"/>
															<xs:element name="specify-yes" type="rdm:radiobutton"/>
															<!-- 2.2.4.4 -->
															<xs:element name="Contact-details">
																	<xs:complexType>
																		<xs:complexContent>
																			<xs:extension base="rdm:contact-details-type">
																				<xs:sequence>
																					<xs:element name="Telephone" type="xs:string"/>
																					<xs:element name="Email" type="xs:string"/>
																					<xs:element name="Number" type="xs:string"/>
																				</xs:sequence>
																			</xs:extension>
																		</xs:complexContent>
																	</xs:complexType>
															</xs:element>														
															</xs:sequence>
														</xs:complexType>
													</xs:element>
															
													<xs:element name="Med-devices-checkbox-e" type="rdm:yes-no"/>
													<xs:element name="Med-devices-subSections-e" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
															<!-- 2.2.4.1 -->
															<xs:element name="Device-name" type="xs:string"/>
															<xs:element name="Device-description" type="xs:string"/>
															<xs:element name="Device-purpose" type="xs:string"/>
															<xs:element name="Device-classification" type="rdm:radiobutton"/>
															<xs:element name="Device-serial-no" type="xs:string"/>
															<xs:element name="sterile" type="rdm:yes-no"/>
															<xs:element name="measuring_function" type="rdm:yes-no"/>
															<xs:element name="reusable" type="rdm:yes-no"/>
															<!-- 2.2.4.2 -->
															<xs:element name="Device-manufacturer" type="rdm:radiobutton"/>
															<xs:element name="Manufacture-contact-details" type="rdm:contact-details-type"/>
															<!-- 2.2.4.3 -->
															<xs:element name="confirm-compliance" type="rdm:yes-no"/>
															<xs:element name="explain-no" type="xs:string"/>
															<xs:element name="specify-yes" type="rdm:radiobutton"/>
															<!-- 2.2.4.4 -->
															<xs:element name="Contact-details">
																	<xs:complexType>
																		<xs:complexContent>
																			<xs:extension base="rdm:contact-details-type">
																				<xs:sequence>
																					<xs:element name="Telephone" type="xs:string"/>
																					<xs:element name="Email" type="xs:string"/>
																					<xs:element name="Number" type="xs:string"/>
																				</xs:sequence>
																			</xs:extension>
																		</xs:complexContent>
																	</xs:complexType>
															</xs:element>														
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													</xs:sequence>
													</xs:complexType>
													</xs:element>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										
										<!-- 2.2.5 -->
										<xs:element name="Companion-diagnostic">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="companion-diagnosis-rb" type="rdm:yes-no"/>
													<xs:element name="sSections2_2_5_2-4" maxOccurs="unbounded">
															<xs:complexType>
															<xs:sequence>
															<xs:element name="Device-info" type="xs:string"/>
															<xs:element name="competent_Authority_planned" type="xs:string"/>
															<xs:element name="Notified-body">
																<xs:complexType>
																	<xs:sequence>
																		<xs:element name="Contact-details">
																			<xs:complexType>
																				<xs:complexContent>
																					<xs:extension base="rdm:contact-details-type">
																						<xs:sequence>
																						<xs:element name="Telephone" type="xs:string"/>
																						<xs:element name="Email" type="xs:string"/>
																						<xs:element name="Number" type="xs:string"/>
																						</xs:sequence>
																					</xs:extension>
																				</xs:complexContent>
																			</xs:complexType>
																		</xs:element>
																	</xs:sequence>
																</xs:complexType>
															</xs:element>
															</xs:sequence>
															</xs:complexType>
													</xs:element>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										
										
										<xs:element name="legal-status">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="subject_to_prescription" type="rdm:yes-no"/>
													<xs:element name="subject_to_prescription_details" minOccurs="0" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="subject-package-size" type="xs:string"/>
																<xs:element name="subject-member-states" type="rdm:member-states"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="non_subject_to_prescription" type="rdm:yes-no"/>
													<xs:element name="non_subject_to_prescription_details" minOccurs="0" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="non-subject-package-size" type="xs:string"/>
																<xs:element name="non-subject-member-states" type="rdm:member-states"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="subject-medical-prescription">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="renewed" type="rdm:yes-no"/>
																<xs:element name="renewed-member-states" type="rdm:member-states"/>
																<xs:element name="not-renewed" type="rdm:yes-no"/>
																<xs:element name="not-renewed-member-states" type="rdm:member-states"/>
																<xs:element name="special" type="rdm:yes-no"/>
																<xs:element name="special-member-states" type="rdm:member-states"/>
																<xs:element name="restricted" type="rdm:yes-no"/>
																<xs:element name="restricted-member-states" type="rdm:member-states"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="not-subject-medical-prescription">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="pharmacy" type="rdm:yes-no"/>
																<xs:element name="pharmacy-member-states" type="rdm:member-states"/>
																<xs:element name="non-pharmacy" type="rdm:yes-no"/>
																<xs:element name="non-pharmacy-member-states" type="rdm:member-states"/>
																<xs:element name="health-care-Professional" type="rdm:yes-no"/>
																<xs:element name="helath-care-member-states" type="rdm:member-states"/>
																<xs:element name="public-health-care-Professional" type="rdm:yes-no"/>
																<xs:element name="public-member-states" type="rdm:member-states"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="contact-blood-vaccines">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="contact-blood-vaccine" type="rdm:contact-blood-vaccine" minOccurs="1" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="contact-product-defects">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="contact-product-defect" type="rdm:contact-details-type" minOccurs="1" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="manufacturer-batch-releases">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="manufacturer-batch-release" type="rdm:manufacturer-batch-release" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="manufacturer-pharmaceutical-products">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="manufacturer-pharmaceutical-product" type="rdm:manufacturer-pharmaceutical-product" minOccurs="1" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="manufacturer-active-substances">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="manufacturer-active-substance" type="rdm:manufacturer-active-substance" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="manufacturer-batch-testing-sites">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="manufacturer-batch-testing-site" type="rdm:manufacturer-batch-testing-site" minOccurs="1" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="contact-during-procedures">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="contact-during-procedure" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="member-states" type="rdm:member-states"/>
																<xs:element name="contact-details" type="rdm:contact-details-type" maxOccurs="unbounded"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="contact-after-procedures">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="contact-after-procedure" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="member-states" type="rdm:member-states"/>
																<xs:element name="contact-details" type="rdm:contact-details-type" maxOccurs="unbounded"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="contact-pharmaco-vigilances">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="contact-pharmaco-vigilance" type="rdm:contact-details-type" maxOccurs="unbounded"/>
													<xs:element name="details-pharmaco-vigilance" type="rdm:pharmaco-vigilance" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="contact-scientific-advices">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="contact-scientific-advice" type="rdm:contact-scientific-advice" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="centralised-nationalprocedure" type="rdm:yes-no"/>
										<xs:element name="marketing-authorisation-holders">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="marketing-authorisation-holder" type="rdm:marketing-authorisation-holder" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="marketing-authorisation-holders-sme">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="marketing-authorisation-holders-sme" type="rdm:contact-details-type" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="contract-companies">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="contract-study" type="rdm:contract-study" minOccurs="0" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="compositions">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="medicinal-product" type="rdm:medicinal-product" maxOccurs="unbounded"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="materials">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="none" type="rdm:yes-no"/>
													<xs:element name="material" minOccurs="1" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="none" type="rdm:yes-no"/>
																<xs:element name="function" type="rdm:radiobutton"/>
																<xs:element name="substance" type="rdm:substance"/>
																<xs:element name="animal-origin-tse" type="rdm:yes-no"/>
																<xs:element name="animal-origin" type="rdm:yes-no"/>
																<xs:element name="other-animal-origin" type="rdm:yes-no"/>
																<xs:element name="human-origin" type="rdm:yes-no"/>
																<xs:element name="certificate-suitable-tse" type="rdm:yes-no"/>
																<xs:element name="tse-numbers">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="tse-number" type="rdm:string30" minOccurs="1" maxOccurs="unbounded"/>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="annex5-13" type="rdm:yes-no"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="pmfs">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="is-certificate-issued" type="rdm:yes-no"/>
													<xs:element name="annex5-21" type="rdm:yes-no"/>
													<xs:element name="pmf" minOccurs="1" maxOccurs="unbounded">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="substance" type="rdm:substance"/>
																<xs:element name="function"/>
																<xs:element name="substance-certificate" type="rdm:substance-certificate" maxOccurs="unbounded"/>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="gmo">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="is-gmo" type="rdm:yes-no"/>
													<xs:element name="directive" type="rdm:yes-no"/>
													<xs:element name="annex5-13" type="rdm:yes-no"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
									</xs:sequence>
								</xs:complexType>
							</xs:element>
							<xs:element name="section-4">
								<xs:complexType>
									<xs:sequence>
										<xs:element name="section4-1-1" type="rdm:yes-no"/>
										<xs:element name="section4-1-1_NA" type="rdm:yes-no"/>
										<xs:element name="section4-1-2">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="yes-member" type="rdm:yes-no"/>
													<xs:element name="member-state" type="rdm:yes-no"/>
													<xs:element name="elaborate"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="section4-1-3">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="yes-member" type="rdm:yes-no"/>
													<xs:element name="elaborate"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="section4-2" minOccurs="0">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="authorised" type="rdm:mark-auth"/>
													<xs:element name="pending" type="rdm:mark-auth"/>
													<xs:element name="refused" type="rdm:mark-auth"/>
													<xs:element name="withdrawn-before" type="rdm:mark-auth"/>
													<xs:element name="withdrawn-after" type="rdm:mark-auth"/>
													<xs:element name="suspended" type="rdm:mark-auth"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="section4-3" minOccurs="0">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="na" type="rdm:yes-no" minOccurs="0"/>
													<xs:element name="mult-duplicates">
														<xs:complexType>
															<xs:sequence>
																<xs:element name="application" maxOccurs="unbounded">
																	<xs:complexType>
																		<xs:sequence>
																			<xs:element name="product-name" type="rdm:string250"/>
																			<xs:element name="date-application" type="xs:date"/>
																			<xs:element name="applicant" type="rdm:string100"/>
																			<xs:element name="attach-copy" type="rdm:yes-no"/>
																			<xs:element name="procedure-number" type="xs:string"/>
																		</xs:sequence>
																	</xs:complexType>
																</xs:element>
															</xs:sequence>
														</xs:complexType>
													</xs:element>
													<xs:element name="attach-copy" type="rdm:yes-no"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
										<xs:element name="section4-4" minOccurs="0">
											<xs:complexType>
												<xs:sequence>
													<xs:element name="authorised" type="rdm:mark-auth"/>
													<xs:element name="pending" type="rdm:mark-auth"/>
													<xs:element name="refused" type="rdm:mark-auth"/>
													<xs:element name="withdrawn-before" type="rdm:mark-auth"/>
													<xs:element name="withdrawn-after" type="rdm:mark-auth"/>
													<xs:element name="suspended" type="rdm:mark-auth"/>
												</xs:sequence>
											</xs:complexType>
										</xs:element>
									</xs:sequence>
								</xs:complexType>
							</xs:element>
							<xs:element name="section-5" minOccurs="0">
								<xs:complexType>
									<xs:sequence>
										<xs:element name="section5-1" type="rdm:yes-no"/>
										<xs:element name="section5-2" type="rdm:yes-no"/>
										<xs:element name="section5-3" type="rdm:yes-no"/>
										<xs:element name="section5-4" type="rdm:yes-no"/>
										<!--  <xs:element name="section5-5" type="rdm:yes-no"/> empty with revision 10 of form.  -->
										<xs:element name="section5-6" type="rdm:yes-no"/>
										<xs:element name="section5-7" type="rdm:yes-no"/>
										<xs:element name="section5-8" type="rdm:yes-no"/>
										<xs:element name="section5-9" type="rdm:yes-no"/>
										<xs:element name="section5-10" type="rdm:yes-no"/>
										<xs:element name="section5-11" type="rdm:yes-no"/>
										<xs:element name="section5-12" type="rdm:yes-no"/>
										<xs:element name="section5-13" type="rdm:yes-no"/>
										<xs:element name="section5-14" type="rdm:yes-no"/>
										<xs:element name="section5-15" type="rdm:yes-no"/>
										<xs:element name="section5-16" type="rdm:yes-no"/>
										<xs:element name="section5-17" type="rdm:yes-no"/>
										<xs:element name="section5-18" type="rdm:yes-no"/>
										<xs:element name="section5-19" type="rdm:yes-no"/>
										<xs:element name="section5-20" type="rdm:yes-no"/>
										<xs:element name="section5-21" type="rdm:yes-no"/>
										<xs:element name="section5-22" type="rdm:yes-no"/>
										<xs:element name="section5_23" type="rdm:yes-no"/>
									</xs:sequence>
								</xs:complexType>
							</xs:element>
						</xs:sequence>
					</xs:complexType>
				</xs:element>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
</xs:schema>
